an US FTC clears AbbVie’s buy of Allergan, but with divestments By www.thepharmaletter.com Published On :: Wed, 06 May 2020 10:05:00 +0100 Almost a year after the original announcement, the US Federal Trade Commission (FTC) has accepted the… Full Article AbbVie/Allergan/Companies mergers and acquisitions/Endocrinology/Federal Trade Commission/Ireland/Legal/Management/Pancrelipase/Pharmaceutical/USA/Viokace/Zenpep
an Gilead plans to meet rising tide of remdesivir demand By www.thepharmaletter.com Published On :: Wed, 06 May 2020 10:21:00 +0100 California’s Gilead Sciences has outlined a plan to ramp up production of newly USA-approved COVID-19… Full Article Anti-virals/Coronavirus/Focus On/Gilead Sciences/Pharmaceutical/Production/Public health/Remdesivir/USA
an Alexion exceeds earnings estimates but drops guidance By www.thepharmaletter.com Published On :: Wed, 06 May 2020 15:22:00 +0100 US drugmaker Alexion Pharmaceuticals fared better in its revenue and adjusted earnings figures in the… Full Article Alexion Pharmaceuticals/Autoimmune Disorders/Biotechnology/Financial/Immunologicals/Management/Rare diseases/Soliris/Strensiq/Ultomiris/USA
an Bausch + Lomb licenses Stada and Xbrane’s Lucentis biosimilar By www.thepharmaletter.com Published On :: Wed, 06 May 2020 16:52:00 +0100 Eye health specialist Bausch + Lomb, part Bausch Health Companies, has entered into an exclusive licensing… Full Article Bausch & Lomb/Bausch Health Companies/Biosimilars/Canada/Deals/Germany/Licensing/Lucentis/Ophthalmics/STADA Arzneimittel/Sweden/USA/Xbrane Biopharma AB/Xlucane
an Bausch Health and partners settle Xifaxan IP litigation By www.thepharmaletter.com Published On :: Wed, 06 May 2020 17:28:00 +0100 Canada-based Bausch Health Companies, along with its wholly-owned subsidiary, Salix Pharmaceuticals and… Full Article Alfasigma/Bausch Health Companies Inc./Canada/Deals/Legal/Licensing/Nephrology and Hepatology/Patents & Trademarks/Pharmaceutical/Salix Pharmaceuticals Ltd/Sandoz/Switzerland/USA/Xifaxan
an An important option in the fight against antimicrobial resistance By www.thepharmaletter.com Published On :: Wed, 06 May 2020 17:33:00 +0100 Positive Phase III data for Recarbrio (imipenem/cilastatin/relebactam) have been announced by New Jersey,… Full Article Antibiotics and Infectious diseases/Biotechnology/Drug Trial/Merck & Co/Recarbrio/Regulation/Research/US FDA/USA
an Global pharma and biotech’s fight against COVID-19: an investment perspective By www.thepharmaletter.com Published On :: Wed, 06 May 2020 18:01:00 +0100 Mark Brewer, who heads up the life sciences team at UK broker and M&A advisory company, finnCap, gives… Full Article Actemra/Anti-virals/Avacta/Avigan/Biotechnology/Business Financing/Chloroquine/Coronavirus/Cytiva/Expert View/Faron Pharmaceuticals/favipiravir/Focus On/Fujifilm/Gilead Sciences/Hydroxychloroquine/In Depth/Medical Devices and Diagnostics/Novacyt/Remdesivir/Roche/SNG001/Synairgen/UK
an Checkpoint blocker plus chemo shows impact in lung cancer By www.thepharmaletter.com Published On :: Thu, 07 May 2020 10:30:00 +0100 A multi-year collaboration between China’s Innovent Biologics and USA-based Eli Lilly is bearing fruit,… Full Article Biotechnology/China/Drug Trial/Eli Lilly & Company/Gemzar/Immuno-oncology/Innovent Biologics/Research/Tyvyt/USA
an BRIEF—GSK completes sale of nutrition brands for £3.4 billion By www.thepharmaletter.com Published On :: Thu, 07 May 2020 10:44:00 +0100 GlaxoSmithKline has completed divestment of its Horlicks and other Consumer Healthcare nutrition products… Full Article Companies mergers and acquisitions/Deals/Financial/GlaxoSmithKline/India/Pharmaceutical/UK
an First targeted therapy for aggressive form of lung cancer approved by FDA By www.thepharmaletter.com Published On :: Thu, 07 May 2020 11:10:00 +0100 Late Wednesday, the US Food and Drug Administration said it has granted accelerated approved for Tabrecta… Full Article Biotechnology/capmatinib/Focus On/Incyte Corp/Medical Devices and Diagnostics/Novartis/Oncology/Rare diseases/Regulation/Research/Switzerland/Tabrecta/USA
an Mediolanum buys French I-O company By www.thepharmaletter.com Published On :: Thu, 07 May 2020 15:33:00 +0100 Privately-held Italian pharma group Mediolanum Farmaceutici has acquired the French immuno-oncology specialist… Full Article Biotechnology/Companies mergers and acquisitions/Elsalys Biotech/France/Immuno-oncology/Italy/Leukotac/Mediolanum/Oncology
an B-MS’ quarterly financials exceed estimates By www.thepharmaletter.com Published On :: Thu, 07 May 2020 17:36:00 +0100 US pharma major Bristol-Myers Squibb saw its revenue reach $10.8 billion in the first quarter of 2020,… Full Article Bristol-Myers Squibb/Cardio-vascular/Celgene/Eliquis/Financial/Hematology/Immuno-oncology/Immunologicals/Management/Oncology/Opdivo/Orencia/Pharmaceutical/Pomalyst/Revlimid/USA
an BetterLife Pharma inks licensing deal for AntiCovir By www.thepharmaletter.com Published On :: Fri, 08 May 2020 13:48:00 +0100 Canada-based BetterLife Pharma, previously known as Pivot Pharmaceuticals, has entered into an agreement… Full Article Altum Pharmaceuticals/Anti-virals/AntiCovir/BetterLife Pharma/Biotechnology/Canada/Coronavirus/Deals/Focus On/Licensing/Research
an Japan grants ‘exceptional’ approval for remdesivir in COVID-19 By www.thepharmaletter.com Published On :: Fri, 08 May 2020 14:53:00 +0100 As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,… Full Article Anti-virals/Asia Pacific/Coronavirus/Focus On/Gilead Sciences/Japan/Pharmaceutical/Regulation/Remdesivir/USA/Veklury
an Recordati 1st-qtr revenues rise 12% as income leaps more than 20% By www.thepharmaletter.com Published On :: Sat, 09 May 2020 10:50:00 +0100 Italian drugmaker Recordati has reported consolidated revenues for the first quarter of 2020 are 429.2… Full Article Financial/Italy/Pharmaceutical/Recordati/Signifor
an FDA backs Retevmo for certain lung and thyroid cancers By www.thepharmaletter.com Published On :: Sat, 09 May 2020 12:27:00 +0100 The US Food and Drug Administration has granted accelerated approval for Retevmo (selpercatinib) capsules… Full Article Biotechnology/Eli Lilly/Focus On/Immuno-oncology/Loxo Oncology/Oncology/Regulation/Retevmo/selpercatinib/US FDA/USA
an BRIEF—AbbVie finally completes acquisition of Allergan By www.thepharmaletter.com Published On :: Sat, 09 May 2020 14:18:00 +0100 US pharma major AbbVie has finally completed its $63 billion acquisition of Ireland-incorporated Allergan,… Full Article AbbVie/Allergan/Companies mergers and acquisitions/Ireland/Legal/Pharmaceutical/USA
an Gilead in talks to expand COVID-19 hopeful remdesivir supply chains with outside partner By www.fiercepharma.com Published On :: Fri, 01 May 2020 14:30:25 +0000 Gilead Sciences scored a massive win earlier this week with its first positive data readout for investigational candidate remdesivir in treating patients with severe COVID-19. Gilead already has its own supply of the drug humming in anticipation of high demand, but opportunities are out there for a partner to join in. Full Article
an AbbVie CEO: Don't worry, Allergan's aesthetics clients still have money—and 'strong desire' for treatment By www.fiercepharma.com Published On :: Fri, 01 May 2020 15:20:40 +0000 AbbVie may be working through COVID-19, but it's pressing ahead with its Allergan merger, too—and taking stock of products hit by pandemic lockdowns. That puts Allergan’s aesthetics business top of mind, but AbbVie CEO Rick Gonzalez figures customers are ready and able to return quickly for treatment. Full Article
an Novartis taps real-life Cosentyx patients to thank healthcare workers, pledge patient support By www.fiercepharma.com Published On :: Sat, 02 May 2020 21:13:54 +0000 Novartis is using familiar faces—real patients from its Cosentyx TV commercials—to thank healthcare workers and promise support for patients. It’s a shift away from product-centered TV ads as Novartis adjusts its Cosentyx DTC effort during the COVID-19 crisis to highlight resources for patients, the drugmaker said. Full Article
an With the world waiting, Roche socks $459M into COVID-19 antibody test production By www.fiercepharma.com Published On :: Mon, 04 May 2020 15:05:01 +0000 Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality. Now, to cover its booming production goals, Roche plans to infuse nearly half-a-billion dollars into its German manufacturing facility. Full Article
an Remdesivir, check. Now, analysts are looking ahead to 'several' COVID-19 drugs to come By www.fiercepharma.com Published On :: Mon, 04 May 2020 15:22:41 +0000 Gilead made waves on Friday with its emergency FDA approval for remdesivir quickly on the heels of a controlled trial data release. But while it’s an important first step, other COVID-19 medicines will likely be coming down the line, analysts wrote. Full Article
an Seattle Genetics, Astellas' bladder cancer med Padcev blows early expectations out of the water By www.fiercepharma.com Published On :: Tue, 05 May 2020 15:21:47 +0000 Even a pandemic can’t slow down Seattle Genetics and Astellas' new bladder cancer treatment Padcev, which "blew out sales expectations" for the first quarter, analysts said. And now, they're jacking up their long-term sales estimates for the drug as a result. Full Article
an AbbVie, Allergan score FTC approval for $63B merger with one final hurdle left to go By www.fiercepharma.com Published On :: Tue, 05 May 2020 17:50:19 +0000 AbbVie and Allergan have waited for nearly a year for their much-discussed merger to pass muster. Finally, after pushback from consumer groups and tight scrutiny from regulators, the FTC has granted its green light. The partners face just one final hurdle to consummating their deal. Full Article
an Ousted BARDA director pushed back on chloroquine claims and faced whistleblower retaliation, complaint says By www.fiercepharma.com Published On :: Tue, 05 May 2020 19:56:27 +0000 After his surprise removal from HHS’ Biomedical Advanced Research and Development Authority—a key agency partnered with pharma companies on COVID-19 drugs, vaccines and diagnostics—former Director Rick Bright is alleging whistleblower retaliation by HHS leadership. Full Article
an AstraZeneca's Farxiga scores landmark FDA nod in heart failure patients with or without diabetes By www.fiercepharma.com Published On :: Wed, 06 May 2020 14:42:58 +0000 AstraZeneca has watched superstar SGLT2 diabetes med Farxiga nail trial after trial in highly coveted kidney and heart failure indications, with the FDA expediting reviews to back them up. The one thing AstraZeneca was missing? The agency taking Farxiga across the finish line. Full Article
an Fresenius Kabi recalls anti-inflammation drug Ketorolac after finding particles in vials By www.fiercepharma.com Published On :: Wed, 06 May 2020 15:25:53 +0000 German drugmaker Fresenius Kabi has made major investments in its U.S. manufacturing operations in recent years with some mixed quality results along the way. Now, one of the drugmaker's products faces a recall for more manufacturing woes. Full Article
an Amgen ramps up Otezla expansion effort with positive data in mild psoriasis By www.fiercepharma.com Published On :: Wed, 06 May 2020 18:22:16 +0000 Amgen is planning to file for FDA approval of Otezla in mild to moderate plaque psoriasis based on new data showing patients on the drug experienced significant improvements in their symptoms. The label expansion will be key to Amgen's ability to recoup the $13.4 billion it paid to acquire the drug from Celgene last year. Full Article
an Pfizer tags 3 U.S. manufacturing sites for possible COVID-19 vaccine launch By www.fiercepharma.com Published On :: Thu, 07 May 2020 13:38:33 +0000 Global coronavirus vaccine makers have been rolling out details about their manufacturing and launch plans—even ahead of any clinical data. Now, Pfizer says it will draw on three sites in the U.S., plus one in Belgium, for the early stages of a launch, provided its BioNTech-partnered shot wins a green light. Full Article
an Can the price be right? With the world watching, Gilead faces a no-win decision on remdesivir By www.fiercepharma.com Published On :: Thu, 07 May 2020 14:40:24 +0000 The world is waiting for Gilead Sciences to set a price tag for remdesivir, the first brand-new med authorized to treat COVID-19. Its choice will affect Gilead's reputation and bottom line, set a tone for follow-up meds—and either help polish up the pharma industry's image or create a new flashpoint for criticism. Full Article
an Biogen gears up Swiss manufacturing facility for potential aducanumab rollout By www.fiercepharma.com Published On :: Thu, 07 May 2020 14:51:06 +0000 Biogen has had a rocky road with its controversial Alzheimer's disease candidate aducanumab, resurrected late last year. But despite postponing the drug's FDA filing half a year, Biogen is still moving forward with plans to scale up production if aducanumab eventually passes muster. Full Article
an Bristol Myers Squibb's blood thinner Eliquis soars on COVID-19 demand, but Opdivo could suffer: execs By www.fiercepharma.com Published On :: Thu, 07 May 2020 14:53:18 +0000 Bristol Myers Squibb CEO Giovanni Caforio credited COVID-19-related stocking for high sales of some products in the first quarter, including Eliquis, a blood thinner that's being snapped up to reduce clotting risk in patients with the virus. But the pandemic has limited access to oncology clinics and other non-COVID-19 services, raising challenges that could impact sales later this year. Full Article
an GBT chief blames COVID-19 for 'clear' slowdown in Oxbryta launch, but analysts are still impressed By www.fiercepharma.com Published On :: Thu, 07 May 2020 18:11:22 +0000 Global Blood Therapeutics' sickle cell disease medicine Oxbryta got off to a hot start after a November FDA approval. But early in its launch, execs now say they're seeing a "clear headwind" from the COVID-19 pandemic. Lately, new patient starts have tanked by 60%, CEO Ted Love said. Full Article
an FiercePharmaAsia—Gilead's Japanese remdesivir nod, licensing talks; Lilly-Junshi COVID-19 antibody pact By www.fiercepharma.com Published On :: Fri, 08 May 2020 10:10:53 +0000 Gilead Sciences' remdesivir, now called Veklury, has won a fast Japanese nod in SARS-CoV-2. The Big Biotech's scouting licensing partners to ramp up supply around the world. Eli Lilly has signed on China's Junshi Biosciences to develop neutralizing antibodies against the novel coronavirus. And more. Full Article
an Cadila shutters Indian ingredients plant after 26 workers test positive for COVID-19: report By www.fiercepharma.com Published On :: Fri, 08 May 2020 13:40:29 +0000 Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections. Full Article
an Early missteps, transparency questions dog U.S. government's remdesivir rollout: reports By www.fiercepharma.com Published On :: Fri, 08 May 2020 13:50:52 +0000 When Gilead Sciences scored a groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the U.S. government. But the federal rollout has gotten off to a rocky start. Full Article
an Roche's Kadcyla wins NICE backing in early breast cancer use By www.fiercepharma.com Published On :: Fri, 08 May 2020 14:47:29 +0000 Unlike its first U.K. reimbursement negotiations, Roche’s HER2 antibody-drug conjugate has won quick National Institute for Health and Care Excellence backing for routine NHS coverage to prevent HER2-positive breast cancer from returning after surgery in the so-called adjuvant setting. Full Article
an Gilead hit with Iranian cyberattack for role in COVID-19 response: report By www.fiercepharma.com Published On :: Fri, 08 May 2020 19:43:17 +0000 Gilead Sciences has captured worldwide attention with its COVID-19 antiviral, remdesivir, cleared late last week by the FDA—not all of it welcome. With bad actors targeting companies at the head of the spear in the pandemic response, Gilead may have found itself in their sights. Full Article
an Germany's confirmed coronavirus cases rise by 1,251 to 168,551: RKI By feeds.reuters.com Published On :: Fri, 08 May 2020 22:09:29 -0400 The number of confirmed coronavirus cases in Germany increased by 1,251 to 168,551, data from the Robert Koch Institute (RKI) for infectious diseases showed on Saturday. Full Article healthNews
an FDA commissioner in self-quarantine after exposure to person with COVID-19 By feeds.reuters.com Published On :: Sat, 09 May 2020 00:38:14 -0400 U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday. Full Article healthNews
an Thailand reports four new coronavirus cases, one new death By feeds.reuters.com Published On :: Sat, 09 May 2020 01:23:35 -0400 Thailand reported four new coronavirus cases and one more death on Saturday, bringing the total to 3,004 cases and 56 deaths since the outbreak started in January. Full Article healthNews
an Russia records more than 10,000 new coronavirus cases in past day By feeds.reuters.com Published On :: Sat, 09 May 2020 04:07:00 -0400 Russian authorities said on Saturday they had recorded 10,817 new cases of the coronavirus in the last day, pushing the nationwide tally to 198,676. Full Article healthNews
an Malaysia reports 54 new coronavirus cases and one new death By feeds.reuters.com Published On :: Sat, 09 May 2020 05:37:14 -0400 Malaysia health authorities on Saturday reported 54 new coronavirus cases for a total of 6,589. Full Article healthNews
an Tijuana coronavirus death rate soars after hospital outbreaks By feeds.reuters.com Published On :: Sat, 09 May 2020 07:16:27 -0400 The number of deaths from the coronavirus in Mexico's best-known border city, Tijuana, has soared and the COVID-19 mortality rate is twice the national average, the health ministry says, after medical staff quickly fell ill as the outbreak rampaged through hospital wards. Full Article healthNews
an Portugal's low-income households struggle to survive pandemic By feeds.reuters.com Published On :: Sat, 09 May 2020 08:02:25 -0400 One in four Portuguese with a monthly household income of 650 euros ($705) or less have lost all their income because of the economic impact of the coronavirus outbreak, a study by the National School of Public Health showed on Saturday. Full Article healthNews
an Half of Spaniards will see lockdown eased from Monday as death toll falls By feeds.reuters.com Published On :: Sat, 09 May 2020 10:11:10 -0400 Spain's daily death toll from the coronavirus fell to its second lowest since mid-March on Saturday, as half the country prepared to move to the next phase of an exit from one of Europe's strictest lockdowns. Full Article healthNews
an FDA grants emergency use authorization to Quidel for first antigen test for COVID-19 By feeds.reuters.com Published On :: Sat, 09 May 2020 11:01:00 -0400 The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test. Full Article healthNews
an Journal Watch (January 2020) By www.biotechduediligence.com Published On :: Sat, 01 Feb 2020 03:27:26 GMT Important paper out on #Wuhan #nCoV2019 via @biorxivpreprint96% sequence identity to a bat #coronavirus~80% sequence identity to SARS~95% AA sequence identity in 7 conserved replicase domains to SARSuses the same cell entry receptor, ACE2, as SARShttps://t.co/iwaHTsDGJN pic.twitter.com/dGEjBvGx4j— Andy Biotech (@AndyBiotech) January 23, 2020This is major progress in understanding #Parkinsons disease biology!~ #LRRK2 atomic resolution #cryoEM structure~ Switch between active / inactive conforma [...] Full Article journal watch
an Puerto Rico Senator Jorge De Castro Font Pleads Guilty to Honest Services Wire Fraud and Conspiracy to Commit Extortion By www.justice.gov Published On :: Wed, 21 Jan 2009 14:18:53 EST Jorge De Castro Font, 45, a former senator in the Commonwealth of Puerto Rico, pleaded guilty today to 20 counts of honest services wire fraud and one count of conspiracy to commit extortion. Full Article OPA Press Releases
an LAN Cargo S.A., Aerolinhas Brasileiras S.A. and EL AL Israel Airlines Ltd. Agree to Plead Guilty for Fixing Prices on Air Cargo Shipments By www.justice.gov Published On :: Thu, 22 Jan 2009 11:57:56 EST Three air cargo carriers, LAN Cargo S.A. (LAN Cargo), Aerolinhas Brasileiras S.A. (ABSA), and EL AL Israel Airlines Ltd. (EL AL), have each agreed to plead guilty and pay criminal fines totaling $124.7 million for their roles in a conspiracy to fix prices in the air cargo industry. Full Article OPA Press Releases