re First French case of COVID-19 occurred in December, a month earlier than previously thought By www.pharmafile.com Published On :: Tue, 05 May 2020 11:46:00 +0000 A French patient who suffered from pneumonia in December actually had COVID-19, it has been revealed. Full Article coronavirus COVID-19 Manufacturing and Production
re Jonathan Freve joins Galecto as Chief Financial Officer By www.pharmafile.com Published On :: Tue, 05 May 2020 16:50:41 +0000 The biotech company Galecto Inc have appointed Jonathan Freve as its Chief Financial Officer, and in his role he will lead financial operations including overseeing investor relations and fundraising efforts. read more Full Article Manufacturing and Production
re Ousted chief of BARDA says Trump administration ignored COVID-19 warnings By www.pharmafile.com Published On :: Wed, 06 May 2020 09:33:46 +0000 Ousted Director of the Biomedical Advanced Research and Development Authority (BARDA), Dr Rick Bright, alleges the Trump administration ignored warnings about the severity of the coronavirus. Full Article BARDA chloroquine coronavirus COVID-19 hydroxychloroquine Research and Development
re AZ's Farxiga becomes first FDA-approved SGLT2 inhibitor for heart failure with reduced ejection fraction By www.pharmafile.com Published On :: Wed, 06 May 2020 11:28:32 +0000 The FDA has moved to approve an oral tablet formulation of AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of cardiovascular death and hospitalisation in adult patients with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction. Full Article AstraZeneca farxiga FDA heart failure Research and Development Sales and Marketing
re South Korea says Ebola drug remdesivir may not be suitable for all coronavirus patients By www.pharmafile.com Published On :: Wed, 06 May 2020 11:29:32 +0000 South Korea says that remdesivir, traditionally used in treating Ebola, may not be effective enough in treating COVID-19 patients. Full Article coronavirus COVID-19 Research and Development south korea
re Scientists in the UK and US identify hundreds of mutations in the COVID-19 virus By www.pharmafile.com Published On :: Thu, 07 May 2020 09:42:57 +0000 Two studies from the UK and US have identified hundreds of mutations in COVID-19, which could cause problems for the development of a vaccine. Full Article coronavirus COVID-19 Protein virus Business Services
re FDA approval for Tabrecta in metastatic non-small cell lung cancer with METex14 By www.pharmafile.com Published On :: Thu, 07 May 2020 11:35:49 +0000 The FDA has awarded marketing authorisation to Novartis for the Oral MET inhibitor Tabrecta for the first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14), regardless of whether they have previously received any type of treatment. Full Article Incyte Novartis pharma Tabrecta Sales and Marketing
re Black people are four times more likely to die from COVID-19 than white in England and Wales, ONS report shows By www.pharmafile.com Published On :: Thu, 07 May 2020 11:53:35 +0000 A recent report from the Office of National Statistics (ONS) has shown that black people in Britain are four times more likely to die from the COVID-19 coronavirus than white Britons. Full Article coronavirus COVID-19 Business Services
re NICE gives thumbs-up to Roche's Kadcyla in HER2+ breast cancer sub-population By www.pharmafile.com Published On :: Thu, 07 May 2020 12:00:39 +0000 NICE has revealed that it has recommended the NHS use of Roche’s Kadcyla (trastuzumab emtansine) for HER2+ breast cancer in patients who have residual invasive disease in the breast or lymph nodes after receiving neoadjuvant treatment including a HER2-targeted agent. Full Article breast cancer cancer Kadcyla NHS NICE Roche UK Sales and Marketing
re EMA starts rolling review of Gilead’s COVID-19 hope remdesivir By www.pmlive.com Published On :: Fri, 01 May 2020 13:01:24 +0100 New crop of data suggests drug can speed recovery from COVID-19 Full Article
re US clears emergency use of Gilead’s remdesivir By www.pmlive.com Published On :: Mon, 04 May 2020 12:32:39 +0100 Move comes after drug showed preliminary efficacy in clinical trial in late April Full Article
re 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
re 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
re COVID-19 Core Formula By www.flickr.com Published On :: Fri, 08 May 2020 11:07:04 -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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
re 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
