v Oxford COVID-19 vaccine programme opens for clinical trial recruitment By www.pharmanews.eu Published On :: Thu, 23 Apr 2020 10:00:00 +0200 University of Oxford researchers working in an unprecedented vaccine development effort to prevent COVID-19 have started screening healthy volunteers (aged 18-55) for their upcoming ChAdOx1 nCoV-19 vaccine trial in the Thames Valley Region. The vaccine based on an adenovirus vaccine vector and the SARS-CoV-2 spike protein is already in production but won’t be ready for some weeks still. Full Article Featured Research Research & Development
v AstraZeneca and Saint Luke’s Mid America Heart Institute initiate Phase III DARE-19 trial with Farxiga in COVID-19 patients By www.pharmanews.eu Published On :: Fri, 24 Apr 2020 10:00:00 +0200 AstraZeneca and Saint Luke's Mid America Heart Institute have initiated a randomised, global Phase III trial to assess the potential of Farxiga (dapagliflozin) as a treatment in patients hospitalised with COVID-19 who are at risk of developing serious complications, such as organ failure. Full Article Featured AstraZeneca Business
v Key nose cells identified as likely COVID-19 virus entry points By www.pharmanews.eu Published On :: Mon, 27 Apr 2020 10:00:00 +0200 Two specific cell types in the nose have been identified as likely initial infection points for COVID-19 coronavirus. Scientists discovered that goblet and ciliated cells in the nose have high levels of the entry proteins that the COVID-19 virus uses to get into our cells. The identification of these cells by researchers from the Full Article Featured Research Research & Development
v Loss of smell associated with milder clinical course in COVID-19 By www.pharmanews.eu Published On :: Tue, 28 Apr 2020 10:00:00 +0200 Following an earlier study that validated the loss of smell and taste as indicators of SARS-CoV-2 infection, researchers at UC San Diego Health report in newly published findings that olfactory impairment suggests the resulting COVID-19 disease is more likely to be mild to moderate, a potential early indicator that could help health care providers determine which patients may require hospitalization. Full Article Featured Research Research & Development
v 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
v AstraZeneca and Oxford University announce landmark agreement for COVID-19 vaccine By www.pharmanews.eu Published On :: Thu, 30 Apr 2020 10:00:00 +0200 AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2. The collaboration aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford. Full Article Featured AstraZeneca Business
v Antibodies from llamas could help in fight against COVID-19 By www.pharmanews.eu Published On :: Fri, 01 May 2020 10:00:00 +0200 The hunt for an effective treatment for COVID-19 has led one team of researchers to find an improbable ally for their work: a llama named Winter. The team - from The University of Texas at Austin, the National Institutes of Health and Ghent University in Belgium - reports their findings about a potential avenue for a coronavirus treatment involving llamas on May 5 in the journal Cell. Full Article Featured Research Research & Development
v Researchers identify four possible treatments for COVID-19 By www.pharmanews.eu Published On :: Mon, 04 May 2020 10:00:00 +0200 While COVID-19 has infected millions of people worldwide and killed hundreds of thousands, there is currently no vaccine. In response, researchers have been evaluating the effectiveness of various antiviral drugs as possible COVID-19 treatments. Full Article Featured Research Research & Development
v 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
v Study reveals most critically ill patients with COVID-19 survive with standard treatment By www.pharmanews.eu Published On :: Wed, 06 May 2020 10:00:00 +0200 Clinicians from two hospitals in Boston report that the majority of even the sickest patients with COVID-19 - those who require ventilators in intensive care units - get better when they receive existing guideline-supported treatment for respiratory failure. The clinicians, who are from Massachusetts General Hospital (MGH) and Beth Israel Deaconess Medical Center, published their findings in the American Journal of Respiratory and Critical Care Medicine. Full Article Featured Research Research & Development
v Repurposing existing drugs for COVID-19 offers a more rapid alternative to a vaccine By www.pharmanews.eu Published On :: Thu, 07 May 2020 10:00:00 +0200 Repurposing existing medicines focused on known drug targets is likely to offer a more rapid hope of tackling COVID-19 than developing and manufacturing a vaccine, argue an international team of scientists in the British Journal of Pharmacology today. Since the emergence of the SARS-CoV-2 virus in late 2019, more than 3.5 million people are known to have been infected, leading to over 240,000 deaths worldwide from COVID-19, the disease caused by the novel coronavirus. Full Article Featured Research Research & Development
v Vitamin D linked to low virus death rate By www.pharmanews.eu Published On :: Fri, 08 May 2020 10:00:00 +0200 A new study has found an association between low average levels of vitamin D and high numbers of COVID-19 cases and mortality rates across 20 European countries. The research, led by Dr Lee Smith of Anglia Ruskin University (ARU) and Mr Petre Cristian Ilie, lead urologist of Queen Elizabeth Hospital King's Lynn NHS Foundation Trust, is published in the journal Aging Clinical and Experimental Research. Full Article Featured Research Research & Development
v COVID-19 leading to shortage of orphan drugs in Russia By www.thepharmaletter.com Published On :: Tue, 05 May 2020 10:09:00 +0100 The ongoing spread of COVID-19 in Russia is leading to shortages of drugs against orphan diseases in… Full Article Anti-virals/Coronavirus/Focus On/From our correspondent/Hydroxychloroquine/In Depth/Pharmaceutical/Public health/Rare diseases/Russia/Russian market
v Firms ready RNAi candidate for COVID-19 development By www.thepharmaletter.com Published On :: Tue, 05 May 2020 10:27:00 +0100 A collaboration in COVID-19 between immunology specialist Vir Biotechnology and Alnylam Pharmaceuticals… Full Article Alnylam Pharmaceuticals/Anti-virals/Biotechnology/Cell and Gene Therapy/Coronavirus/Focus On/Public health/Research/USA/Vir Biotechnology/VIR-2703
v 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
v Clinical tests imminent for Junshi's COVID-19 antibody By www.thepharmaletter.com Published On :: Tue, 05 May 2020 13:11:00 +0100 A new collaboration between Shanghai’s Junshi Biosciences and Eli Lilly will seek to develop novel… Full Article Anti-virals/Biotechnology/China/Coronavirus/Drug Trial/Eli Lilly & Company/Focus On/JS016/Junshi Biosciences/Research/USA
v 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
v China and COVID-19 offer test case for blockchain By www.thepharmaletter.com Published On :: Tue, 05 May 2020 15:25:00 +0100 The COVID-19 pandemic did not stop China from launching its national blockchain-based service network… Full Article China/Coronavirus/Digital Pharma/Focus On/GlobalData/Pharmaceutical
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v Stockpiling spurs sales at Novo Nordisk in first quarter By www.thepharmaletter.com Published On :: Wed, 06 May 2020 15:14:00 +0100 Pandemic-based stockpiling among people with diabetes helped lift revenues beyond analysts’ expectations… Full Article Biotechnology/Denmark/Diabetes/Financial/Management/Novo Nordisk/Ozempic/Research/Rybelsus/Tresiba/USA/Victoza
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
v 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
