on Sanofi, Regeneron set up another niche use for PD-1 drug Libtayo By www.pmlive.com Published On :: Wed, 06 May 2020 11:57:45 +0100 Drug has shown “clinically meaningful responses” for basal cell carcinoma Full Article
on Coronavirus contact-tracing app trial to begin on the Isle of Wight By www.pmlive.com Published On :: Wed, 06 May 2020 12:06:00 +0100 Initial roll-out will see key workers utilise the app Full Article
on US trials of Pfizer/BioNTech coronavirus vaccine start By www.pmlive.com Published On :: Wed, 06 May 2020 12:16:48 +0100 It is hoped that the drug may prevent COVID-19 Full Article
on Regeneron says antibody for COVID-19 could be ready this year By www.pmlive.com Published On :: Thu, 07 May 2020 15:59:05 +0100 Two antibody cocktails for COVID-19 could be available as early as this autumn Full Article
on Glutagenic Virus Protection Kit By www.flickr.com Published On :: Thu, 07 May 2020 08:13:37 -0700 The U.S. Food and Drug Administration posted a photo: This product is promoted with unapproved claims to prevent, treat, mitigate, or cure COVID-19. FDA warns consumers to avoid unproven and potentially unsafe products. See the Warning Letter for more information: www.fda.gov/inspections-compliance-enforcement-and-crimin... More information is available at www.fda.gov/consumers/health-fraud-scams/fraudulent-coron... Photo by FDA's Office of Regulatory Affairs, Health Fraud Branch This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to FDA's Office of Regulatory Affairs, Health Fraud Branch is appreciated but not required. Full Article
on Protection Blend By www.flickr.com Published On :: Fri, 08 May 2020 11:07:05 -0700 The U.S. Food and Drug Administration posted a photo: This product is promoted with unapproved claims to prevent, treat, mitigate, or cure COVID-19. FDA warns consumers to avoid unproven and potentially unsafe products. See the Warning Letter for more information: www.fda.gov/inspections-compliance-enforcement-and-crimin... More information is available at www.fda.gov/consumers/health-fraud-scams/fraudulent-coron... Photo by FDA's Office of Regulatory Affairs, Health Fraud Branch This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to FDA's Office of Regulatory Affairs, Health Fraud Branch is appreciated but not required. Full Article
on Endo, Allergan Nearing Deals to Limit Ohio Litigation Over Opioids - Report By www.thestreet.com Published On :: Tue, 20 Aug 2019 07:23:05 EDT Click to view a price quote on AGN. Full Article
on Elanco to Buy Bayer's Animal Health Business for $7.6 Billion By www.thestreet.com Published On :: Tue, 20 Aug 2019 09:35:13 EDT Click to view a price quote on ELAN. Full Article
on Lannett to Be U.S. Distributor of Posaconazole Delayed-Release Tablets By www.thestreet.com Published On :: Wed, 28 Aug 2019 08:18:15 EDT Click to view a price quote on LCI. Full Article
on Rick Simpson Oil (RSO): Benefits, Effects and Research By www.thestreet.com Published On :: Tue, 18 Feb 2020 10:42:15 EST Click to view a price quote on TLRY. Full Article
on Oligonucleotide Therapeutics and Delivery Conference 2020 By www.pharmanews.eu Published On :: Wed, 22 Apr 2020 10:00:00 +0200 16 - 17 September 2020, London, UK. Oligonucleotide therapeutics - the emerging medicine class - are harnessing the therapeutic benefit of targeting genetic material via antisense, mRNA, RNAi, saRNA and siRNA. Their market growth: CAGR of 13.7% projected to reach USD 8.2 billion by 2024 is driven by their potential to provide more efficacious and less toxic alternatives to small molecules. Full Article Featured Events
on Novartis announces plan to initiate clinical trial of canakinumab for patients with COVID-19 pneumonia By www.pharmanews.eu Published On :: Wed, 29 Apr 2020 10:00:00 +0200 Novartis announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. The CAN-COVID trial will examine the efficacy of utilizing canakinumab, an interleukin (IL)-1β blocker, to treat a type of severe immune overreaction called cytokine release syndrome (CRS) in people with COVID-19 pneumonia. Full Article Featured Novartis Business
on Supercomputer simulations present potential active substances against coronavirus By www.pharmanews.eu Published On :: Tue, 05 May 2020 10:00:00 +0200 Several drugs approved for treating hepatitis C viral infection were identified as potential candidates against COVID-19, a new disease caused by the SARS-CoV-2 coronavirus. This is the result of research based on extensive calculations using the MOGON II supercomputer at Johannes Gutenberg University Mainz (JGU). One of the most powerful computers in the world, Full Article Featured Research Research & Development
on Pre-filled Syringes San Francisco Conference 2020 By www.pharmanews.eu Published On :: Tue, 05 May 2020 12:00:00 +0200 14 - 15 September 2020, San Francisco, USA. The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design and delivery systems within the prefilled syringe industry. Full Article Featured Events
on India remains on USTR list of IP problem countries By www.thepharmaletter.com Published On :: Mon, 04 May 2020 16:58:00 +0100 India continues to be on the 'Priority Watch List' of the US Trade Representative (USTR) for lack of… Full Article Focus On/Generics/India/Intellectual property law/Legal/Patents & Trademarks/USA
on US-Swiss partnership takes aim at rare heart condition By www.thepharmaletter.com Published On :: Mon, 04 May 2020 17:15:00 +0100 A new collaboration targeting rare heart diseases has been formed between California’s BioMarin Pharmaceutical… Full Article BioMarin Pharmaceutical/Biotechnology/Cardio-vascular/Deals/DiNA-001/DiNAQOR/Licensing/Rare diseases/Research/Switzerland/USA
on Mallinckrodt’s INOmax successful in trial of neonates with pulmonary hypertension By www.thepharmaletter.com Published On :: Mon, 04 May 2020 17:20:00 +0100 UK-based Mallinckrodt Pharmaceuticals has ended a trial of INOmax (nitric oxide) gas early due to positive… Full Article Drug Trial/Inomax/Mallinckrodt/Nitric Oxide/Pharmaceutical/Research/Respiratory and Pulmonary/UK
on European progress in long path for Lokelma By www.thepharmaletter.com Published On :: Tue, 05 May 2020 10:08:00 +0100 The European medicines regulator has OK’d a label update for AstraZeneca’s Lokelma (sodium zirconium… Full Article AstraZeneca/Biotechnology/Cardio-vascular/Drug Trial/Europe/European Medicines Agency/Focus On/Lokelma/Regulation/Research/UK
on Positive Phase III data for Lupin’s trichomoniasis candidate By www.thepharmaletter.com Published On :: Tue, 05 May 2020 11:03:00 +0100 India’s Lupin has announced positive top-line results from its pivotal Phase III clinical trial to… Full Article Antibiotics and Infectious diseases/Drug Trial/India/Lupin/Pharmaceutical/Research/Solosec/Symbiomix Therapeutics/Women's health
on Menarini nabs hematologic malignancy drug along with buy of Stemline By www.thepharmaletter.com Published On :: Tue, 05 May 2020 12:32:00 +0100 Privately-held pharma and diagnostics firm Menarini Group has announced a definitive agreement to acquire… Full Article Biotechnology/Companies mergers and acquisitions/Elzonris/Hematology/Italy/Menarini Group/Oncology/One to Watch Companies/Rare diseases/Stemline Therapeutics/USA
on EU brings production home amid supply chain worries By www.thepharmaletter.com Published On :: Tue, 05 May 2020 14:37:00 +0100 Specialty chemicals company Evonik has kicked off a major expansion project at two German facilities,… Full Article Europe/Evonik/Generics/Germany/Production
on EU-led coronavirus fundraiser targets initial 7.5 billion euros By www.thepharmaletter.com Published On :: Tue, 05 May 2020 15:20:00 +0100 A pledging conference led by the European Union (EU) has set an initial target of 7.5 billion euros ($8.1… Full Article Anti-virals/Antibiotics and Infectious diseases/Coronavirus/EIB Group/Europe/Focus On/Government Affairs/Health Medical Pharma/Pharmaceutical/Public health
on Pfizer and BioNTech move on COVID-19 vaccine work apace By www.thepharmaletter.com Published On :: Tue, 05 May 2020 16:43:00 +0100 As with other companies, US drug giant Pfizer and its German partner BioNTech are moving forward their… Full Article BioNTech/BNT162/Coronavirus/Drug Trial/Focus On/Pfizer/Pharmaceutical/Research/USA/Vaccines
on Regeneron rockets as financial results provide perfect picture of growth By www.thepharmaletter.com Published On :: Tue, 05 May 2020 17:29:00 +0100 Investors in Regeneron could afford a rare smile in these difficult times, as the company’s first quarter… Full Article Anti-virals/Biotechnology/Dermatologicals/Dupixent/Eylea/Financial/Immuno-oncology/Inflammatory diseases/Libtayo/Management/Oncology/Ophthalmics/Regeneron/REGN-COV2/USA
on Akebia soars on positive Ph III trial results for vadadustat By www.thepharmaletter.com Published On :: Tue, 05 May 2020 19:20:00 +0100 Shares of US biotech Akebia Therapeutics were up more than 35% at $11.72 by early afternoon today, after… Full Article Akebia Therapeutics/Biotechnology/Drug Trial/Nephrology and Hepatology/Research/USA/vadadustat
on ALK Abello outperforms expectations in strong 1st-qtr By www.thepharmaletter.com Published On :: Wed, 06 May 2020 11:08:00 +0100 Shares of Danish allergy immunotherapy specialist ALK Abello were up almost 10% at 1,788.00 Danish kroner… Full Article Acarizax/ALK Abello/Denmark/Financial/Immunologicals/Itulazax/Pharmaceutical
on Portola agrees to takeover bid from Alexion By www.thepharmaletter.com Published On :: Wed, 06 May 2020 12:26:00 +0100 Following a couple of active M&A years, USA-based Alexion Pharmaceuticals has now reached a definitive… Full Article Alexion Pharmaceuticals/AndexXa/Anticoagulants/Biotechnology/Cardio-vascular/Companies mergers and acquisitions/Hematology/Ondexxya/Portola Pharmaceuticals/USA
on BRIEF—Key appointments at Denmark’s Acesion Pharma By www.thepharmaletter.com Published On :: Wed, 06 May 2020 13:57:00 +0100 Danish drugmaker Acesion Pharma, which is focused on novel treatments for atrial fibrillation (AF), has… Full Article Acesion Pharma/Boardroom/Cardio-vascular/Denmark/Management/Pharmaceutical
on FDA approval for Farxiga in new indication in heart failure patients By www.thepharmaletter.com Published On :: Wed, 06 May 2020 14:59:00 +0100 Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and… Full Article AstraZeneca/Cardio-vascular/Diabetes/Farxiga/Focus On/Glucosides/Pharmaceutical/Regulation/SGLT2 inhibitors/UK/US FDA/USA
on 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
on 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
on 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
on Assessing the long-term impact of COVID-19 on clinical research By www.thepharmaletter.com Published On :: Thu, 07 May 2020 10:15:00 +0100 The fallout from the COVID-19 pandemic has been challenging for many life sciences companies due to a… Full Article Anti-virals/Cell and Gene Therapy/Coronavirus/CRA/Feature/Focus On/Global/In Depth/Pharmaceutical/Regulation/Research/Vaccines
on 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
on Novel ADC continues on path to blockbuster status By www.thepharmaletter.com Published On :: Thu, 07 May 2020 15:39:00 +0100 Tokyo’s Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) for trastuzumab deruxtecan… Full Article Asia Pacific/AstraZeneca/Biotechnology/Daiichi Sankyo/Enhertu/Focus On/Japan/Oncology/Regulation/Research/trastuzumab deruxtecan/UK
on Teva soars as 1st-qtr beats expectations By www.thepharmaletter.com Published On :: Thu, 07 May 2020 17:21:00 +0100 Israel-based Teva Pharmaceutical Industries today reported results for the quarter ended March 31, 2020,… Full Article Ajovy/Analgesia/Austedo/Copaxone/Financial/Generics/Israel/Musculoskeletal/Rare diseases/Teva Pharmaceutical Industries/Treanda
on 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
on 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
on jCyte out-licenses rare vision disorder treatment for $252 million By www.thepharmaletter.com Published On :: Sat, 09 May 2020 14:46:00 +0100 US biotech firm jCyte Inc has entered into a licensing agreement with Japanese ophthalmology specialist… Full Article Biotechnology/Deals/Japan/jCell/jCyte Inc/Licensing/Ophthalmics/Rare diseases/Santen/USA/Vision disorder
on 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
on 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
on 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
on 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
on 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
on 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
on 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
on 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
on 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
on 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
on 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
