m BRIEF—US court upholds Amgen Kyprolis patent By www.thepharmaletter.com Published On :: Tue, 05 May 2020 14:43:00 +0100 The US District Court in Delaware issued a decision upholding the validity of patent claims from three… Full Article Amgen/Biotechnology/Cipla/Focus On/Kyprolis/Legal/Oncology/Patents & Trademarks/USA
m 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
m 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
m 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
m 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
m 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
m Ferring in sight of finish line with first microbiome-based drug By www.thepharmaletter.com Published On :: Wed, 06 May 2020 13:17:00 +0100 Swiss drugmaker Ferring and its Rebiotix subsidiary have announced a world first with a microbiome-based… Full Article Antibiotics and Infectious diseases/Biotechnology/Drug Trial/Ferring Pharmaceuticals/Microbiomes/RBX2660/Rebiotix/Research/Switzerland
m 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
m 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
m Bristol-Myers' CAR-T cell therapy meets with FDA delay By www.thepharmaletter.com Published On :: Wed, 06 May 2020 15:23:00 +0100 The submission of additional information, upon the request of the US regulator, has delayed the action… Full Article Biotechnology/Bristol-Myers Squibb/Focus On/Immuno-oncology/lisocabtagene maraleucel/Regulation/Research/US FDA/USA
m BRIEF—Merck invests in AI chip start-up SynSense By www.thepharmaletter.com Published On :: Wed, 06 May 2020 16:10:00 +0100 Germany’s science and technology company Merck KGaA today announced its investment in SynSense (formerly… Full Article China/Companies mergers and acquisitions/Digital Pharma/Germany/Merck KGaA/Pharmaceutical/Switzerland/SynSense
m Otezla’s impact shown in milder psoriasis By www.thepharmaletter.com Published On :: Wed, 06 May 2020 16:46:00 +0100 Amgen’s Otezla (apremilast), a drug divested by Celgene ahead of its acquisition by Bristol-Myers Squibb,… Full Article Amgen/Biotechnology/Dermatologicals/Drug Trial/Inflammatory diseases/Otezla/Research/USA
m 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
m 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
m 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
m 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
m 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
m 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
m 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
m PTC Therapeutics to acquire Censa Pharmaceutical By www.thepharmaletter.com Published On :: Thu, 07 May 2020 14:18:00 +0100 In another strategic M&A deal announced so far this month, PTC Therapeutics has entered into an agreement… Full Article Biotechnology/Censa Pharmaceuticals/Companies mergers and acquisitions/Metabolics/PTC Therapeutics/Rare diseases/sepiapterin/USA
m 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
m Growth forecast for drug delivery systems market By www.thepharmaletter.com Published On :: Thu, 07 May 2020 16:07:00 +0100 COVID-19 is having varying effects on different markets within healthcare, with drug delivery systems… Full Article Anti-virals/Antibiotics and Infectious diseases/Asia Pacific/Biotechnology/Coronavirus/Drug delivery systems/Focus On/Healthcare/Markets & Marketing/Oncology/USA
m Dr Reddy's gets FDA nod for migraine drug Elyxyb By www.thepharmaletter.com Published On :: Thu, 07 May 2020 16:10:00 +0100 Shares of Dr Reddy’s Laboratories rose more than 2% to 3,936.35 rupees, after the Indian drugmaker… Full Article Analgesia/celecoxib/Dr Reddy's Laboratories/Elyxyb/Focus On/India/Migraine/Neurological/Pharmaceutical/Regulation/US FDA/USA
m 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
m 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
m 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
m 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
m 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
m 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
m 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
m 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
m 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
m Gilead's remdesivir scores emergency FDA nod in COVID-19 days after big data reveal By www.fiercepharma.com Published On :: Fri, 01 May 2020 20:01:17 +0000 Days after U.S. officials reported the first positive controlled data for Gilead's remdesivir in COVID-19, the FDA has given the drug an emergency use authorization. Full Article
m 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
m Fair price for Gilead's COVID-19 med remdesivir? $4,460, cost watchdog says By www.fiercepharma.com Published On :: Mon, 04 May 2020 15:09:09 +0000 While Gilead has yet to present a marketing plan for remdesivir—much less a price—ICER figures the COVID-19 drug could be cost-effective at up to $4,460 per patient. That means it could easily rake in blockbuster sales this year, at least theoretically. Full Article
m 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
m 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
m 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
m 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
m 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
m 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
m 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
m 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
m Teva generics benefit from COVID-19 bump––but the boom may not last By www.fiercepharma.com Published On :: Thu, 07 May 2020 13:57:22 +0000 With its multibillion-dollar restructuring plan in the rearview mirror, Teva is pinning its future growth on two of its branded meds with high hopes. But generics are still central to the Israeli drugmaker's business, and increased demand due to COVID-19 gave Teva a welcome gift in the first three months of the year. Full Article
m 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
m 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
m 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
m 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
m 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
m 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