o Newron drops development of sarizotan in Rett syndrome By www.pharmatimes.com Published On :: Tue, 05 May 2020 11:09:35 +0100 The experimental 5-HT1A receptor agonist and D2 receptor antagonist was not effective on primary or secondary endpoints Full Article
o Menarini to buy Stemline for up to $677 million By www.pharmatimes.com Published On :: Tue, 05 May 2020 11:17:09 +0100 The move will establish Menarini's presence in the US biopharma market Full Article
o ICR welcomes new advanced prostate cancer treatment guideline By www.pharmatimes.com Published On :: Wed, 06 May 2020 12:11:18 +0100 NHS England has expanded access to targeted hormone therapies for advanced prostate cancer Full Article
o US OK's AZ' Farxiga for heart failure with reduced ejection fraction By www.pharmatimes.com Published On :: Wed, 06 May 2020 12:13:58 +0100 Farxiga is the first sodium glucose co-transporter 2 inhibitor cleared by the FDA to treat heart failure with reduced ejection fraction Full Article
o NICE publishes rapid COVID-19 guideline for acute kidney injury By www.pharmatimes.com Published On :: Wed, 06 May 2020 12:21:13 +0100 The guideline is designed to help healthcare professionals who are not kidney specialists to prevent, detect and manage AKI in hospitalised patients with suspected or confirmed COVID-19 Full Article
o US regulators permit AbbVie/Allergan merger By www.pharmatimes.com Published On :: Wed, 06 May 2020 12:23:42 +0100 The closing of the acquisition remains subject to other customary closing conditions Full Article
o Aberdeen Uni proceeds with COVID-19 mass screening research By www.pharmatimes.com Published On :: Wed, 06 May 2020 12:34:33 +0100 The Scottish government has given funds £101,903 to support the project Full Article
o Speedy US approval for Novartis' Tabrecta By www.pharmatimes.com Published On :: Wed, 06 May 2020 22:47:33 +0100 The approval gives NSCLC patients whose tumours carry the MET exon 14 skipping mutation a new treatment option Full Article
o Rebiotix, Ferring's microbiome-based therapy RBX2660 shows promise By www.pharmatimes.com Published On :: Wed, 06 May 2020 23:02:02 +0100 RBX2660 may bring an innovative therapeutic option to patients suffering from C. diff Full Article
o Imperial College London partners with NHS Trust to make PPE By www.pharmatimes.com Published On :: Thu, 07 May 2020 07:39:19 +0100 More than 6,000 visors have already been delivered to Charing Cross Hospital Full Article
o Merck names Doina Ionescu as UK and Ireland general manager By www.pharmatimes.com Published On :: Thu, 07 May 2020 07:40:20 +0100 Dr Mike England joins as medical director for UK & ROI Full Article
o E&C Members Hold Bipartisan Teleconference Forum with CDC on Racial Disparities in COVID-19 Health Outcomes By energycommerce.house.gov Published On :: Fri, 01 May 2020 00:00:00 -0400 Members of the Energy and Commerce Committee’s Health and Oversight and Investigations subcommittees today held a bipartisan teleconference forum with Centers for Disease Control and Prevention (CDC) Principal Deputy Director Anne Schuchat, M.D., to discuss racial disparities in health outcomes for COVID-19 patients. Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), Health Subcommittee Ranking Member Michael C. Burgess, M.D. (R-TX), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) and Oversight and Investigations Subcommittee Ranking Member Brett Guthrie (R-KY) released a joint statement following the call: “Today, bipartisan members of our two subcommittees discussed the deeply troubling racial disparities in health outcomes for COVID-19 patients with CDC’s Principal Deputy Director Schuchat. During the call, members received an update on CDC’s COVID-19 response, current data collection efforts, and reiterated the need for more accurate and timely demographic data. “Congress stands ready to work with the CDC to secure comprehensive demographic data to help us direct resources and support to close this gap in these health outcomes.” ### Full Article
o House Health Leaders Oppose Rule to Roll Back ACA Nondiscrimination Protections By energycommerce.house.gov Published On :: Fri, 01 May 2020 00:00:00 -0400 Today, Chairs of the House Committees that oversee the Department of Health and Human Services (HHS) voiced their strong opposition to a harmful Trump Administration rule that would roll back Affordable Care Act (ACA) nondiscrimination protections. In a letter, House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), House Ways and Means Committee Chairman Richard E. Neal (D-MA), House Education and Labor Committee Chairman Bobby Scott (D-VA), and House Oversight and Reform Committee Chairwoman Carolyn B. Maloney (D-NY) urged HHS Secretary Alex Azar not to finalize this troubling rule and to instead focus on responding to the COVID-19 pandemic. The rule would overturn core protections for marginalized communities including LGBTQ+ people, women, individuals with limited English proficiency, and individuals with disabilities, and eliminate many health care programs and activities from coverage of the Affordable Care Act’s nondiscrimination requirements. “At a time when the United States is grappling with the 2019 coronavirus (COVID-19) pandemic and access to health care services is so critical, we are disappointed that this Administration is once again taking steps to limit access to health care and embolden discrimination against some of the most vulnerable among us,” the Chairs wrote. “If finalized, this dangerous rule would open the door to discrimination against patients in express contradiction to the plain language and intent of the law, and would therefore be illegal. Undermining protections for marginalized individuals at any time is unacceptable, but it is particularly egregious to do so during the worst global pandemic in over a century.” Read the full letter to Secretary Azar HERE. ### Full Article
o E&C Committee Members Hold Teleconference Forum with Admiral Giroir on COVID-19 Testing By energycommerce.house.gov Published On :: Mon, 04 May 2020 00:00:00 -0400 Energy and Commerce Committee members held a bipartisan teleconference forum with Admiral Brett P. Giroir, M.D., Assistant Secretary of Health at the Department of Health and Human Services, on the Administration’s COVID-19 testing efforts. Chairman Frank Pallone, Jr. (D-NJ) and Ranking Member Greg Walden (R-OR) released a joint statement following the call: “The Committee continued its discussions with federal health leaders today on the Administration’s ongoing response to the coronavirus pandemic. During the call, members received an update on federal efforts to increase COVID-19 testing and encouraged the Administration to continue working to get more testing supplies to communities in need. “The members asked for more specifics on the testing needs that states have identified, how the federal government is going to increase capacity and what level of testing is necessary to reopen the economy. “Testing is an essential tool in reducing the spread of this horrible virus, and we thank Admiral Giroir for providing the Committee an update today.” ### Full Article
o Pallone, Wyden Slam Trump Admin for Excluding Medicaid Providers from COVID-19 Relief Fund By energycommerce.house.gov Published On :: Wed, 06 May 2020 00:00:00 -0400 House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-NJ) and Senate Finance Committee Ranking Member Ron Wyden (D-OR) called on the Trump administration to address the lack of financial relief for Medicaid providers fighting the COVID-19 pandemic. The two Committee leaders voiced concerns that, to date, roughly $70 billion has been distributed to health care providers under the CARES Act in a way that discriminates against Medicaid-dependent health care providers. “HHS’s continued neglect for the needs of Medicaid-dependent providers struggling to deal with the COVID-19 crisis is unacceptable,” the members wrote. “The country is in the middle of a pandemic. The Medicaid program is a first responder, and the providers it relies on must be treated with equity. At a bare minimum that should include expeditious access to the [provider fund] as intended by Congress.” The Provider Relief Fund that Congress created as a part of the CARES Act, within the Public Health and Social Services Emergency Fund (PHSSEF), was intended to support health care providers including those who participate in Medicare and Medicaid. However, to date only Medicare-enrolled providers have been able to access funds, and these funds are being allocated according to a methodology that rewards providers with high levels of privately-insured individuals while providers supporting the safety net are left waiting. This imbalance discriminates against critical health care providers that primarily service the Medicaid population, such as frontline hospitals, nursing homes and home-based providers, behavioral health providers, maternal health care providers and pediatricians. In the letter, sent to Health and Human Services (HHS) Secretary Alex Azar, Pallone and Wyden called on the Trump administration to describe how much funding will go to Medicaid-dependent providers and the steps it has taken to understand the needs of these providers during the pandemic. The full letter is available here. ### Full Article
o E&C Announces Hearing on Protecting Scientific Integrity in COVID-19 Response By energycommerce.house.gov Published On :: Thu, 07 May 2020 00:00:00 -0400 The Energy and Commerce Committee today announced a Health Subcommittee Hearing for Thursday, May 14, entitled “Protecting Scientific Integrity in the COVID-19 Response.” The hearing notice follows this note to the media. NOTE TO THE MEDIA: Due to COVID-19, the Committee will make every effort to adhere to the safety recommendations from the Centers for Disease Control and Prevention (CDC) and the Attending Physician. Therefore, media access will be limited. Please contact your respective gallery for details. As always, congressional press credentials will be required. May 7, 2020 HEARING NOTICE TO: Members of the Subcommittee on Health FROM: Anna G. Eshoo, Chairwoman SUBJECT: Subcommittee Hearing on “Protecting Scientific Integrity in the COVID-19 Response” The Subcommittee on Health of the Committee on Energy and Commerce will hold a hearing on Thursday, May 14, 2020, at 10 a.m. in the John D. Dingell Room, 2123 of the Rayburn House Office Building. The hearing is entitled, “Protecting Scientific Integrity in the COVID-19 Response.” Witnesses will be by invitation only. Among the witnesses invited to testify is Dr. Rick A. Bright, former Director of the Biomedical Advanced Research and Development Authority. The logistics of this hearing will be different due to the current circumstances of conducting a public hearing during the COVID-19 pandemic. Members will be advised regarding specifics on hearing procedures and briefings as soon as they become finalized. If you have any questions, please contact Meghan Mullon with the Committee staff at (202) 225-2927. The U.S. House of Representatives Office Buildings and the U.S. Capitol Complex are currently closed to the public. Official meetings of the Committee and its subcommittees are broadcast and available on the Committee’s website: www.energycommerce.house.gov. ### Full Article
o E&C Leaders Announce Committee Teleconference Forum on COVID-19 Testing, Contact Tracing and Surveillance on May 8 By energycommerce.house.gov Published On :: Thu, 07 May 2020 00:00:00 -0400 Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Ranking Member Greg Walden (R-OR) today announced that the Full Committee will hold a teleconference forum on Friday, May 8, at 12 pm (EDT) on COVID-19 testing, contact tracing and surveillance. “Our nation cannot effectively combat this terrible pandemic in the weeks and months ahead without significant testing, contact tracing and surveillance,” Pallone and Walden said. “We look forward to hearing from health experts about what actions they believe are necessary to ensure our communities have the resources they need to fight this pandemic and to confidently reopen their local economies.” During the forum, the Committee will hear from three health experts: Andy Slavitt, former Acting Administrator of the Centers for Medicare & Medicaid Services (CMS) from 2015-2017. Mark McClellan, M.D., Ph.D., former Administrator of CMS from 2004-2006 and former Commissioner of the Food and Drug Administration (FDA) from 2002-2004. Avik Roy,Co-founder and President of the Foundation for Research on Equal Opportunity. This forum is open to the press. Credentialed reporters interested in listening to the forum live should RSVP to cj.young@mail.house.gov by 4 pm today, Thursday, May 7. ### Full Article
o Consumer Protection and Commerce Subcommittee Announces Teleconference Forum with FTC Chairman Simons on May 11 By energycommerce.house.gov Published On :: Thu, 07 May 2020 16:35:29 -0400 Washington, D.C. – Consumer Protection and Commerce Subcommittee Chair Jan Schakowsky (D-IL) and Ranking Member Cathy McMorris Rodgers (R-WA) today announced that the Subcommittee will hold a teleconference forum on Monday, May 11, at 12 p.m. (EDT) with Federal Trade Commission (FTC) Chairman Joseph J. Simons to discuss critical consumer protection issues related to the COVID-19 pandemic. “The COVID-19 pandemic has brought about significant consumer protection concerns that fall under the purview of the FTC, including COVID-19 related scams, price gouging, privacy and data security issues, and more,” Schakowsky and McMorris Rodgers said. “We look forward to hearing from Chairman Simons about the steps FTC is taking to ensure consumers are protected during this pandemic.” This forum is open to the press. Credentialed reporters interested in listening to the forum live should RSVP to Evan.Gilbert@mail.house.gov by 5 pm on Friday, May 8. ### Full Article
o Pallone and Neal Demand Transparency into Methodology and Distribution of COVID-19 Health Care Provider Relief Funds By energycommerce.house.gov Published On :: Thu, 07 May 2020 17:28:14 -0400 Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Ways and Means Chairman Richard E. Neal (D-MA) sent a letter to Health and Human Services (HHS) Secretary Alex Azar and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma today raising a series of concerns over the methodology used to distribute and the lack of transparency into how COVID-19 relief funds and loans for health care providers are being spent. “We write to raise serious concerns about the Provider Relief Fund and the Accelerated and Advance Payment Programs,” Pallone and Neal wrote. “With respect to each, we are concerned about the lack of transparency with Congress and the American people about how funds are being spent or loans are being made. We also have grave concerns regarding the methodology being used to distribute $175 billion Congress appropriated for the Provider Relief Fund.” The Chairmen’s letter documents concerns with how the programs are being run, in particular the Administration’s methodologies for distributing funding that has shortchanged a number of critical providers and makes clear that more transparency is needed for Congress to accurately assess the ongoing needs of health care providers as the COVID-19 crisis unfolds. “The Administration’s efforts to establish the Provider Relief Fund to date has been at best, a series of missteps, and at worst, a disregard of Congress’ intent for the program,” Pallone and Neal continued in their letter. Pallone and Neal wrote that when Congress passed the CARES Act, it was clear that the funding provided to HHS for the Provider Relief Fund was for the express purpose, “to prevent, prepare for, and respond to coronavirus.” The two Chairs voiced concern that some of the funding formulas adopted to date fail to target funding based on the statutory framework relating to COVID-19 driven costs. In fact, the Chairs write that the level of funding appears to be, “completely disconnected from need.” The Chairmen requested an immediate response from HHS regarding documents and information pertaining to the Provider Relief Fund and the Accelerated and Advanced Payment Program. Pallone and Neal also wrote that if HHS is unable to immediately provide the information, it should provide a timeline of when the Committees would receive the requested information. While recognizing the incredible demands on the Department at this difficult time, the Chairmen emphasized that, “This crisis demands that we work swiftly and based on the best data available. Currently, despite repeated requests, this Administration has prevented Congress from obtaining the data that the Department has available on funding for our health care system, data that is necessary to inform near future legislation. We look forward to receiving this information so that we can conduct the business the American people expect of us. We look forward to having you join us at the earliest possible date in each of our Committees to discuss these and other COVID-related issues.” To read the full letter, click HERE. ### Full Article
o House Chairs Press Trump Administration to Rescind Policies that Delay Release of Migrant Children By energycommerce.house.gov Published On :: Fri, 08 May 2020 12:18:57 -0400 May 8, 2020 (WASHINGTON) – Today, several House committee and subcommittee chairs sent a letter to the Departments of Homeland Security (DHS) and Health & Human Services (HHS) regarding recent news reports alleging that the Trump Administration is considering implementing policies that could unnecessarily delay migrant children in HHS care from being reunified with their sponsors. The chairs again urge the Administration to rescind a Memorandum of Agreement requiring information about sponsors for migrant children be shared by HHS with DHS. A group of House chairs previously wrote the Administration on this issue last July. Despite current law, Congressional directives, and the current COVID-19 epidemic, the Administration continues policies that will lengthen the time migrant children spend in HHS care, thus keeping these children in congregate settings and therefore at heightened risk for exposure to COVID-19. There have been 68 confirmed cases of COVID-19 among children in HHS care. The letter, led by Rep. Bennie G. Thompson (D-MS), Chairman of the Homeland Security Committee, has also been signed by: Rep. Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Committee; Rep. Jerrold Nadler (D-NY), Chairman of the Judiciary Committee; Rep. Nita Lowey (D-NY), Chairwoman of the Appropriations Committee; Rep. Lucille Roybal-Allard (D-CA), Chairwoman of the Homeland Security Appropriations Subcommittee; Rep. Rosa DeLauro (D-CT), Chair of the Labor, Health and Human Services, and Education Appropriations Subcommittee; Rep. Kathleen Rice (D-NY), Chairwoman of the Homeland Security Committee Border Security, Facilitation, and Operations Subcommittee; Rep. Zoe Lofgren (D-CA), Chair of the Judiciary Committee Immigration and Citizenship Subcommittee; and Rep. Diana DeGette (D-CO), Chair of the Energy and Commerce Committee Oversight and Investigations Subcommittee. Link to letter Letter text: We write with deep concern over recent reporting alleging that Administration officials are considering implementing policies that could unnecessarily delay the reunification of unaccompanied minors in the care of the Department of Health and Human Services (HHS) with their sponsors. These concerns are heightened by the current COVID-19 epidemic, which poses significant risks for all individuals held in congregate settings. We are particularly wary of expanded information sharing under the Memorandum of Agreement (MOA) between your Departments. As we wrote last summer, we continue to have strong concerns that the MOA, which has been used in the past to deport a child’s family and loved ones, will have a chilling effect on reunifications by forcing migrant families to choose between sponsoring children and risking arrest. The effect of that policy undermines the best interests of children in HHS care. This is particularly dangerous given the ongoing coronavirus pandemic, which has already resulted in 68 confirmed cases of COVID-19 among children in ORR care, including 38 children within just one facility in Illinois. HHS previously fingerprinted all adults in a sponsor’s household for a period of about six months in 2018. However, according to HHS Administration for Children and Families (ACF) Assistant Secretary Lynn Johnson, HHS found that the extra screening did not add to the protection or safety of the children. In addition, the HHS Office of the Inspector General (OIG) found that the MOA resulted in children spending a significantly increased length of time in HHS care, reaching an average length of stay of 93 days in November 2018. The OIG found that the length of stay declined as HHS reduced fingerprinting requirements. The Administration must not revisit a policy that has been found to be detrimental to the interests of the children in its care. We find it extremely troubling that both the Department of Homeland Security (DHS) and HHS are reportedly considering ignoring Congressional directives and reimplementing policies that are expected to delay the placement of children in HHS care with sponsors. The law has been clear – the Administration is not to deter potential sponsors from coming forward by using information shared under the MOA for deportation purposes, except in very limited, specified circumstances. Yet DHS’ Immigration and Customs Enforcement (ICE) violated the law and utilized the information collected from adults deemed ineligible for sponsorship for deportation purposes. ICE’s continued use of data collected by HHS for the placement of children in safe homes also represents a violation of the law. In addition, Congress directed HHS in the Fiscal Year 2020 Further Consolidated Appropriations Act not to reverse operational directives from 2018 and 2019 that reduced the length of time children spent in HHS care. Congress also directed HHS to “continue to work on efforts to reduce time in care and to consider additional policy changes that can be made to release children to suitable sponsors as safely and expeditiously as possible.” We urge you to prioritize the safety and wellbeing of children in your care and rescind the MOA. In the midst of the COVID-19 epidemic, this should also include taking all reasonable measures to release children in your care to sponsors as quickly as possible. Thank you in advance for your consideration of these requests. # # # Full Article
o Hearing on Protecting Scientific Integrity in the COVID-19 Response By energycommerce.house.gov Published On :: Thu, 14 May 2020 10:00:00 -0400 The Subcommittee on Health of the Committee on Energy and Commerce will hold a hearing on Thursday, May 14, 2020, at 10 a.m. in the John D. Dingell Room, 2123 of the Rayburn House Office Building. The hearing is entitled, “Protecting Scientific Integrity in the COVID-19 Response.” Full Article
o Bio Roundup: Remdesivir Data, Erasca’s $200M, a New FDA Nod & More By xconomy.com Published On :: Fri, 01 May 2020 12:55:07 +0000 Remdesivir, the investigational Gilead Sciences antiviral drug, looks more likely than ever to become the first treatment authorized by the FDA to treat patients with COVID-19. National Institute of Allergy and Infectious Diseases (NIAID) head Anthony Fauci praised the drug after preliminary data released this week from a federally funded trial involving more than 1,000 […] Full Article Boston blog main Boston top stories Boulder/Denver blog main Boulder/Denver top stories Detroit blog main Detroit top stories Europe blog main Europe top stories Indiana blog main Indiana top stories National National blog main National top stories New York blog main New York top stories Raleigh-Durham blog main Raleigh-Durham top stories San Diego blog main San Diego top stories San Francisco blog main San Francisco top stories Seattle blog main Seattle top stories Texas blog main Texas top stories Wisconsin blog main Wisconsin top stories ADC Therapeutics Adicet Bio Affinia Therapeutics Akili Interactive Alphabet Alzheimer's disease AMAG Anthony Fauci Aurinia Avadel Pharmaceuticals Avalyn Pharma Axsome Therapeutics BioNtech Biotech cancer clinical trials coronavirus COVID-19 Dascena David Cook Depression Digital Health Drug Development Erasca FDA Financing Forma Gene Therapy Genespire Gilead Sciences google Idiopathic Pulmonary Fibrosis Imvax IPO Joe Miller Kelly Martin Life Sciences Lymphoma Lyra Therapeutics Machine Learning Mark Exley Martin Huber Mirum ModeRNA National Institute of Allergy and Infectious Diseases Neurocrine Biosciences neurodegeneration Parkinson's Disease Pear Therapeutics Pfizer Radius Regeneron Pharmaceuticals remdesivir resTORbio Roche Rome Therapeutics San Raffaele-Telethon Institute for Gene Therapy Sanofi Scott Myers SuperNus Pharmaceuticals US WorldMeds Vaccine Valneva Venture Capital Vertex Pharmaceuticals Xilio
o Lyra Therapeutics IPO Raises $56M for Tests of Tech for Runny Noses By xconomy.com Published On :: Fri, 01 May 2020 16:31:22 +0000 Lyra Therapeutics, a biotech company developing a new way to treat your persistently runny nose, has raised $56 million in its public markets debut. Late Thursday, Lyra offered 3.5 million shares priced at $16 apiece, which was the high end of its projected $14 to $16 price range. Those shares are expected to begin trading […] Full Article Boston Boston blog main Boston top stories National blog main 480 Biomedical Arsenal Medical Biotech Bob Langer chronic rhinosinusitis clinical trials COVID-19 deals Drug Delivery FDA Genzyme George Whitesides Inflammation investing IPO Keros Therapeutics Life Sciences Lyra Therapeutics Medical Device MIT mometasone furorate North Bridge Venture Partners ORIC Pharmaceuticals Perceptive Advisors Polaris Venture Partners Renaissance Capital startups Zentalis Pharmaceuticals
o FDA Authorizes “Emergency” Use of Gilead’s Remdesivir for Severe COVID-19 By xconomy.com Published On :: Fri, 01 May 2020 21:14:35 +0000 Regulators on Friday afternoon granted emergency authorization for the Gilead Sciences drug remdesivir as a treatment for patients hospitalized with severe COVID-19 infections. The decision makes the antiviral drug, which is delivered via intravenous infusion, the second drug to receive authorization under the FDA’s emergency guidelines for use against the novel coronavirus. The first was […] Full Article National National blog main National top stories Biotech clinical trials FDA Gilead Sciences Life Sciences remdesivir
o Pfizer Pays Valneva $130M for a Bite at a Lyme Disease Vaccine By xconomy.com Published On :: Fri, 01 May 2020 22:44:06 +0000 If you’re looking for a Lyme disease vaccine, you can choose from among several—for your dog. A vaccine for humans hasn’t been available for years and few companies have tried to fill that void. Valneva has advanced its Lyme vaccine candidate to mid-stage clinical testing, and the company now has the help of drug giant […] Full Article Europe National blog main New York blog main New York top stories Biotech Centers for Disease Control and Prevention Cholera clinical trials deals Encephalitis FDA GlaxoSmithKline Japanese encephalitis Life Sciences Lyme disease LYMErix Pfizer pneumococcal disease Prevnar SmithKline Beecham Thomas Lingelbach Valneva
o Backed by $100M, Praxis Aims to Turn Epilepsy Research Into New Neuro Drugs By xconomy.com Published On :: Mon, 04 May 2020 20:44:46 +0000 The genetic mutations that cause epilepsy don’t stop there. Praxis Precision Medicines CEO Marcio Souza says research also links these genes to other neurological conditions. The biotech startup is turning that research into new neuro drugs and it’s coming out of stealth to share details about its science and its pipeline, which already has two […] Full Article Boston Boston blog main Boston top stories National blog main National top stories New York blog main New York top stories antisense oligonucleotide benzodiazepines Biogen Biotech Blackstone Group Blackstone Life Sciences clinical trials Columbia University David Goldstein Depression Epi4K epilepsy Essential Tremor investing Kiran Reddy Life Sciences Major Depressive Disorder Marcio Souza perimenopausal depression Praxis Precision Medicines PTC Therapeutics startups Steven Petrou Third Rock Ventures University of Melbourne Venture Capital
o Stemline Slated for Acquisition by Menarini in Deal Worth Up to $677M By xconomy.com Published On :: Mon, 04 May 2020 20:45:58 +0000 Stemline Therapeutics, whose drug for a rare, aggressive type of acute leukemia was approved by the FDA about 18 months ago, has signed an acquisition deal with Italian biopharma Menarini Group. Stemline (NASDAQ: STML), a New York-based company, developed the first FDA-approved drug for blastic plasmacytoid dendritic cell neoplasm, or BPDCN. The drug, tagraxofusp (Elzonris) […] Full Article Europe blog main National blog main New York New York blog main New York top stories Acquisition Biotech blastic plasmacytoid dendritic cell neoplasm Blood Cancer BPDCN clinical trials Deal Elcin Barker Ergun Ivan Bergstein Life Sciences M&A Menarini Merger Oncology Precision Medicine Stemline Therapeutics transaction
o COVID-19 and Fungal Superinfections: The Deadly, Perfect Storm By xconomy.com Published On :: Tue, 05 May 2020 10:00:45 +0000 Virtually unknown just a few months ago, the COVID-19 pandemic has already resulted in over 239,000 deaths worldwide—including over 67,000 in the United States alone. Now, emerging reports suggest that as many as one third of patients with severe COVID-19 infection requiring intensive care may also be battling another life-threatening infection: invasive aspergillosis, a deadly […] Full Article National blog main San Diego San Diego Xcon Biotech COVID-19 Life Sciences
o Alexion Pharma Boosts Blood Drug Lineup With $1.4B Deal for Portola By xconomy.com Published On :: Tue, 05 May 2020 18:18:24 +0000 Alexion Pharmaceuticals has agreed to buy Portola Pharmaceuticals in a $1.4 billion deal that brings it a first-in-class therapy for treating life-threatening bleeding. According to financial terms announced Tuesday, Boston-based Alexion (NASDAQ: ALXN) will pay $18 for each outstanding share of Portola (NASDAQ: PTLA). That price is a a nearly 132 percent premium to Monday’s […] Full Article Boston Boston top stories Europe blog main National blog main National top stories San Francisco blog main San Francisco top stories Alexion Pharmaceuticals andexanet alfa Ardhana Sarin Betrixaban Biotech Bristol-myers Squibb clinical trials deals eculizumab FDA Geoffrey Porges Life Sciences Ludwig Hantson paroxysmal nocturnal hemoglobinuria Pfizer Portola Pharmaceuticals Ravulizumab SVB Leerink
o Kura Narrows Pipeline After Strategic Review Prompted by COVID-19 By xconomy.com Published On :: Wed, 06 May 2020 03:55:26 +0000 Kura Oncology is discontinuing development of one of its three clinical-stage cancer drug candidates amid pandemic-related impacts to its clinical trial plans. The decision to end work on the drug, KO-947, comes after San Diego-based Kura (NASDAQ: KURA) was successful in lifting a partial clinical hold placed on a Phase 1 trial of the drug […] Full Article National blog main San Diego San Diego blog main San Diego top stories Biotech cancer COVID-19 Drug Development Kura Oncology Life Sciences Syndax Pharmaceuticals Troy Wilson
o Encouraging Signals for New Cancer Cell Therapy Strategies By xconomy.com Published On :: Wed, 06 May 2020 12:14:46 +0000 Chimeric antigen receptor T-cell therapies have shown remarkable efficacy in leukemia and lymphoma patients who relapsed or were refractory to several prior treatments, but many challenges remain in the cancer cell therapy field. Strategies that may improve upon first-generation therapies were presented during the American Association for Cancer Research virtual meeting with encouraging early activity, […] Full Article Boston blog main Boston top stories Boulder/Denver blog main Boulder/Denver top stories Detroit blog main Detroit top stories Europe blog main Europe top stories Indiana blog main Indiana top stories National National blog main New York blog main New York top stories Raleigh-Durham blog main Raleigh-Durham top stories San Diego blog main San Diego top stories San Francisco blog main San Francisco top stories Seattle blog main Seattle top stories Texas blog main Texas top stories Wisconsin blog main Wisconsin top stories Acute Lymphoblastic Leukemia American Association for Cancer Research Biotech cancer Cancer Drugs CAR-T immunotherapy clinical trials FDA Gilead Sciences Gracell Biotechnologies Immunotherapy Iovance Biotherapeutics Kite Pharma Leukemia Life Sciences Melanoma National Cancer Institute Non-Small Cell Lung Cancer Roche University of California at Los Angeles Xinin Wang Yvonne Chen
o Ventus Launches With $60M to Shine Light on Innate Immune System Drugs By xconomy.com Published On :: Wed, 06 May 2020 17:07:49 +0000 The innate immune system has become a hot area for drug development, and for good reason. As the body’s first line of defense, its function (or dysfunction) plays a role in many diseases. The problem, says Ventus Therapeutics CEO Marcelo Bigal, is that drug developers have been working in the dark. Scientists don’t know the […] Full Article Boston Boston blog main Boston top stories National blog main San Diego blog main San Diego top stories San Francisco blog main San Francisco top stories Alphabet Biotech cancer cardiometabolic disorders deals Douglas Green Feng Shao gasdermin Genentech google GV Hao Wu Harvard Medical School IFM Therapeutics Immunology Inflammasome Inflammation Innate Immune System investing Jecure Therapeutics Judy Lieberman Labrys Biologics Life Sciences Marcelo Bigal National Institute of Biological Sciences nonalcoholic steatohepatitis Novartis Osteoarthritis Quench Bio Richard Flavell Roche Russell Vance St. Jude Children's Research Hospital startups Teva Pharmaceutical University of California at Berkeley Venture Capital Ventus Therapeutics Versant Ventures Yale University
o AstraZeneca Diabetes Drug Gets FDA OK for Reducing Heart Health Risks By xconomy.com Published On :: Thu, 07 May 2020 00:24:10 +0000 An AstraZeneca diabetes drug that brought in more than $1.5 billion in sales last year has won an FDA nod expanding its use to adults with systolic heart failure, a condition in which the heart struggles to pump with enough force to push enough blood into circulation. The drug, the once-daily pill dapagliflozin (Farxiga), was […] Full Article Europe blog main National National blog main AstraZeneca Biotech Boehringer Ingelheim diabetes Eli Lilly Heart Failure Life Sciences
o Novartis Drug Wins FDA Approval for Lung Cancers With Specific Mutation By xconomy.com Published On :: Thu, 07 May 2020 01:46:05 +0000 As cancer research reveals the genetic basis of the disease, pharmaceutical companies are pursuing targeted therapies that address certain groups of patients. One such drug from Novartis won FDA approval Wednesday, making it the first therapy cleared by the agency to treat patients whose non-small cell lung cancer (NSCLC) carries a certain genetic mutation. The […] Full Article National National blog main American Cancer Society Biotech cancer Cancer Drugs clinical trials companion diagnostic FDA Foundation Medicine Incyte kinase inhibitor Life Sciences myelofibrosis Novartis ruxolitinib
o PTC Therapeutics to Acquire Censa Pharma for Mid-Stage Rare Disease Drug By xconomy.com Published On :: Thu, 07 May 2020 07:09:51 +0000 PTC Therapeutics has reached an agreement to acquire Censa Pharmaceuticals and its lead asset, an experimental metabolic disorder therapy that is now being prepared for a pivotal study. The deal, announced after the market close Wednesday, will bring South Plainfield, NJ-based PTC (NASDAQ: PTCT) another compound for its pipeline of rare disease drugs. Wellesley, MA-based […] Full Article Boston blog main Boston top stories National blog main New York New York blog main New York top stories Arkin Bio Ventures BioMarin Pharmaceutical Biotech Censa Therapeutics clinical trials Drug Development FDA Life Sciences PTC Therapeutics rare disease
o Join Us Online May 13 for Xcelerating Life Sciences: Biopharma’s Future in Digital Health By xconomy.com Published On :: Thu, 07 May 2020 13:15:48 +0000 Learn how digital tech is accelerating medical breakthroughs by registering your team to attend Xcelerating Life Sciences Boston: Biopharma’s Future in Digital Health. While some content focuses on the Boston ecosystem, we’re confident the forum – and virtual networking – will be valuable to a national audience. The May 13, 2020 event will explore the […] Full Article Boston Boston blog main Boston top stories National National blog main National top stories Biotech event Life Science Life Sciences
o Trovagene Rebrands as Cardiff Oncology, Promotes Longtime Exec to CEO By xconomy.com Published On :: Fri, 08 May 2020 03:46:00 +0000 Trovagene (NASDAQ: TROV), which started out as a diagnostics company, has renamed itself Cardiff Oncology to better reflect its focus on the cancer drug it is advancing in three clinical trials. In 2017 the San Diego area-based biotech made the first step in its transformation into a drug development-focused organization, licensing rights to an investigational […] Full Article National blog main San Diego San Diego blog main San Diego top stories Biotech cancer Cardiff Oncology clinical trials combination therapy Drug Development genetic mutations Life Sciences Mark Erlander Precision Medicine Thomas Adams TrovaGene
o Ayala’s IPO Raises $55M to Test Two Former Bristol Myers Cancer Drugs By xconomy.com Published On :: Fri, 08 May 2020 13:05:23 +0000 Ayala Pharmaceuticals has two clinical-stage cancer drugs licensed from Bristol Myers Squibb. Now it has $55 million to take those drugs further than the pharmaceutical giant did. On Thursday evening, Ayala priced its IPO, which consisted of 3.7 million shares sold for $15 each. That price was the midpoint of the targeted $14 to $16 […] Full Article National National blog main New York blog main New York top stories Acute Lymphoblastic Leukemia Adenoid Cystic Carcinoma Ayala Pharmaceuticals B-cell maturation antigen Biotech Bristol-myers Squibb clinical trials deals Desmoid tumors FDA investing IPO Israel Biotech Fund Life Sciences Novartis Pfizer SpringWorks Therapeutics triple-negative breast cancer
o Bio Roundup: Acquisitive Alexion, CRISPR on COVID, C. diff Success & More By xconomy.com Published On :: Fri, 08 May 2020 14:33:23 +0000 Alexion Pharmaceuticals CEO Ludwig Hantson has made no secret that he wants to diversify his company’s drug portfolio and he has shown willingness to open the corporate checkbook to accomplish that goal. Last October, Alexion (NASDAQ: ALXN) struck a $930 million deal to acquire Achillion Pharmaceuticals, a biotech whose lead drug complements the Boston company’s […] Full Article Boston blog main Boston top stories Boulder/Denver blog main Boulder/Denver top stories Detroit blog main Detroit top stories Europe blog main Europe top stories Indiana blog main Indiana top stories National National blog main National top stories New York blog main New York top stories Raleigh-Durham blog main Raleigh-Durham top stories San Diego blog main San Diego top stories San Francisco blog main San Francisco top stories Seattle blog main Seattle top stories Texas blog main Texas top stories Wisconsin blog main Wisconsin top stories AbbVie Achillion Pharmaceuticals Akcea Therapeutics Alexion Pharmaceuticals Alnylam Pharmaceuticals andexanet alfa Antibe Therapeutics Apotex Arrowhead Pharmaceuticals AstraZeneca Avrobio Axcella Health. Newron Pharmaceuticals basal cell carcinoma BioMarin Pharmaceutical BioNtech Biotech blastic plasmacytoid dendritic cell neoplasm Bristol-myers Squibb Bruce Given cancer Cardiff Oncology Carla Poulson Celgene Cell Therapy cemiplimab Censa Pharmaceuticals Chemotherapy chlorambucil Chronic Lymphocytic Leukemia Clarametyx Biosciences Clostridium difficile COVID-19 CRISPR dapagliflozin Diagnostics DiNAQOR dry eye disease epilepsy Federal Trade Commission Ferring Pharmaceuticals FogPharma Fragile X Syndrome Gemini Therapeutics Gene Therapy Gilead Sciences Grail Incyte Innate Immune System investing Joseph Stauffer Kala Pharmaceuticals Kezar Life Sciences Kura Oncology Life Sciences lisocaptagene maraleucel Ludwig Hantson Magenta Therapeutics Marc Uknis Mark Erlander Menarini Group Microbiome microbiome drugs Myonexus Therapeutics Neurological Diseases Noreen Roth Henig Novartis Obinutuzumab Ovid Therapeutics Pfizer Portola Pharmaceuticals pravastatin Praxis Precision Medicines PTC Therapeutics rare disease drugs rebiotix Regeneron Pharmaceuticals remdesirvir Rett syndrome Sanofi Sarepta Therapeutics sarizotan Sherlock Biosciences startups Stemline Therapeutics systolic heart failure TG Therapeutics Tony Gibney TrovaGene U.S. Department of Justice ublituximab umbralisib Ventus Therapeutics Vir Biotechnology
o 2020 National Xconomy Awards Finalists Will Be Announced on June 22 By xconomy.com Published On :: Fri, 08 May 2020 16:57:32 +0000 Xconomy is excited to announce we’ve had an overwhelming amount of interest in the inaugural National Xconomy Awards. The hundreds of outstanding nominations highlight the groundbreaking, inspiring companies and individuals we look to honor. Stay tuned for when we reveal the finalists on Monday, June 22. Due to COVID-19 we have postponed the planned June […] Full Article National National blog main National top stories exome Life Science Life Sciences xconawards
o Eli Lilly Gets Edge in the “RET” Race With FDA Nod for Cancer Drug By xconomy.com Published On :: Sat, 09 May 2020 02:33:40 +0000 Eil Lilly received accelerated FDA approval Friday for a drug that treats advanced cancers carrying a certain genetic signature. It’s the latest targeted cancer therapy to pass the regulatory bar and the first that addresses tumors characterized by aberrations in one particular gene. The gene in question, RET, produces a protein involved in cell signaling. […] Full Article Boston blog main Boston top stories Indiana Indiana blog main Indiana top stories National blog main National top stories New York blog main New York top stories Biotech Blueprint Medicines cancer Cancer Drugs clinical trials Eli Lilly FDA Life Sciences medullary thyroid cancer Non-Small Cell Lung Cancer Novartis pralsetinib selpercatinib Thyroid Cancer
o GSK hires computational drug design expert Dr Kim Branson as new head of machine learning and AI By www.pharmafile.com Published On :: Wed, 10 Jul 2019 11:24:21 +0000 British multinational GlaxoSmithKline have hired computational drug design expert Dr Kim Branson as the company’s new Senior Vice President, Global Head of Artificial Intelligence and Machine Learning. In his new role, the biotech veteran will oversee projects which use AI to identify novel targets for potential medicines. Dr Branson brings to the role more than 15 years’ worth of experience in biotech and academia having held positions at a number of Silicon Valley firms including Gliimpse, Lumia and Hessian Informatics. read more Full Article Research and Development Medical Communications Sales and Marketing Business Services Manufacturing and Production
o Dr John McHutchinson steps down from Gilead with $1.1 million goodbye By www.pharmafile.com Published On :: Thu, 18 Jul 2019 16:03:27 +0000 Gilead has said that Dr John McHutchison is stepping down after nine years at the firm. Gilead’s Chief Scientific Officer and Head of Research and Development has decided to leave the company next month, Gilead said. Under McHutchinson, Gilead developed five new hepatitis drugs, which have been used by as many as 3.2 million people around the world. read more Full Article Research and Development Medical Communications Sales and Marketing Business Services Manufacturing and Production
o Disarm Therapeutics hires Dr Alvin Shih as new President and CEO By www.pharmafile.com Published On :: Tue, 23 Jul 2019 14:46:45 +0000 Massachusetts-based biotech Disarm Therapeutics has hired Dr Alvin Shih as their new President and CEO. The Cambridge, Mass.-based firm has set itself the task of creating a new class of disease-modifying therapeutics for patients with axonal degeneration, a central drive of neurological disease. Dr Shih brings to the role a range of experiences. Having graduated with a biology degree from Vanderbilt University in 1996, Shih joined management consultancy McKinsey where he worked as a business analyst for two years. read more Full Article Research and Development Medical Communications Sales and Marketing Business Services Manufacturing and Production
o ABPI Chief Executive Mike Thompson to retire by the end of 2019 By www.pharmafile.com Published On :: Wed, 24 Jul 2019 13:18:21 +0000 Chief Executive Mike Thompson is to retire from his role at the Association of the British Pharmaceutical Industry (ABPI) by the end of this year. His decision to leave the association marks the end of a three-year run beginning in March 2016, when stepped in to take up the mantle from Alison Clough, who had served as the acting Chief Executive for much of 2015. read more Full Article Research and Development Medical Communications Sales and Marketing Business Services Manufacturing and Production
o GSK hire Jonathan Symonds as new Chairman By www.pharmafile.com Published On :: Wed, 24 Jul 2019 14:52:08 +0000 Business chief Jonathan Symonds has joined British multinational GlaxoSmithKline as the company’s new non-executive chairman. The hire ends GSK’s six month search, as it prepares to fold its consumer business into a joint venture with Pfizer. In his new role Symonds will oversee the changes being implemented by CEO Emma Walmsley who joined GSK in 2017. Walmsley hopes to revitalise GSK’s R&D efforts with the help of Chief Scientific Officer Hal Barron. read more Full Article Research and Development Medical Communications Sales and Marketing Business Services Manufacturing and Production
o Christi Shaw taken on by Gilead as Kite Pharma's new CEO By www.pharmafile.com Published On :: Thu, 25 Jul 2019 14:43:03 +0000 Lilly veteran Christi Shaw has joined Kite Pharma as the company’s new CEO. Shaw comes to Gilead’s cancer immunotherapy firm, Kite Pharma, from rival US firm Eli Lilly, where she acted as a senior vice president and also as president of Lilly’s immunology, pain and neuroscience unit, Lilly Bio Medicines. read more Full Article Research and Development Medical Communications Sales and Marketing Business Services Manufacturing and Production
o Vertex promote chief medical officer to CEO as Jeffrey Leiden steps down By www.pharmafile.com Published On :: Thu, 25 Jul 2019 15:31:24 +0000 Dr Reshma Kewalramani has been made the new Vertex CEO. Vertex’s Chief Medical Officer Dr Kewalramani will succeed current CEO Jeffrey Leiden who has is now stepping aside from the role after seven years as Chief executive at the Boston-based firm. In stepping down Leiden will serve as executive chairman until the first quarter of 2023. Fourty-six year old Dr Kewalramani, who has been at Vertex since 2017, will thus become the first woman to head the firm. Prior to joining Vertex, Kewalramani spent more than 12 years at Amgen. read more Full Article Research and Development Medical Communications Sales and Marketing Business Services Manufacturing and Production
o Dr Wajid Hussain appointed new clinical director for digital health at RCP By www.pharmafile.com Published On :: Fri, 02 Aug 2019 11:20:05 +0000 The Royal College of Physicians (RCP) has appointed Dr Wajid Hussain as its new clinical director for digital health. Dr Hussain, a cardiologist and cardiac electrophysicist at the Royal Brompton and Harefield NHS Trust, has a demonstrated interest in IT and health. While he currently represents the views of clinicians on the Trust’s IT committee, Dr Hussain completed a Diploma in Digital Health Leadership at the NHS Digital Academy last year. He is also currently studying for a Master’s in Digital Health leadership at Imperial College London. read more Full Article digital health IT pharma RCP Research and Development Royal College of Physicians Medical Communications Sales and Marketing Business Services Manufacturing and Production
o Troy Robinson promoted to managing director of Chugai Pharma Europe By www.pharmafile.com Published On :: Tue, 06 Aug 2019 16:14:25 +0000 Troy Robinson has been taken on as the new managing director of Chugai Pharma Europe. Mike Crosher will succeed him in his current role as managing director of Chugai Pharma UK. Chugai Pharma Europe (CPE) has promoted Troy Robinson and Mike Crosher into the positions of managing director of CPE and managing director of the firm’s UK subsidiary, Chugai Pharma UK (CPU). read more Full Article Research and Development Medical Communications Sales and Marketing Business Services Manufacturing and Production