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Regulatory Focus™ > News Articles > 2020 > 4 > Recon: Merck launches trastuzumab biosimilar in US; Fujifilm boosts Avigan production

Recon: Merck launches trastuzumab biosimilar in US; Fujifilm boosts Avigan production

Posted 15 April 2020 | By Michael Mezher 

Recon: Merck launches trastuzumab biosimilar in US; Fujifilm boosts Avigan production

Editor’s note: Regulatory Recon will be undergoing some changes in the coming weeks as we fine tune its content and presentation to better align with the topics and industries it covers. We value your input as we adapt Recon going forward. Please write to news@raps.org if you have any comments or suggestions.
 
In Focus: US
  • Coronavirus testing hits dramatic slowdown in US (Politico)
  • Trump's halt to WHO funding prompts condemnation as coronavirus cases near 2 million (Reuters)
  • UN chief says 'not the time' to reduce WHO resources after Trump announcement (Reuters)
  • Senate Republicans investigating WHO and China's coronavirus response (NBC)
  • Merck Follows Rivals With US Launch of Trastuzumab Biosimilar (The Center for Biosimilars) (Press)
  • Gilead takes a hit after a Covid-19 trial of remdesivir is quietly terminated (Endpoints) (Reuters)
  • Abbott says new coronavirus antibody test could do 20m screenings in June (CNBC) (Press)
  • Pharmacy reimbursement often lags for generics undergoing price hikes, jeopardizing access (STAT)
  • Novo Nordisk becomes latest insulin maker seeking to foster goodwill amid Covid-19 (STAT)
  • GM begins production of ventilators for US government (Reuters)
  • CDC director says 19-20 US states may be ready to reopen May 1 (Reuters)
  • US FTC tells firms flogging unproven COVID remedies to halt advertising (Reuters)
In Focus: International
  • China didn’t warn public of likely pandemic for 6 key days (AP)
  • EU unveils virus exit plan, hoping to avoid more chaos (AP)
  • EU to limit export control of virus protection gear to just masks (Reuters)
  • Lockdowns should be lifted in two-week stages to stem COVID-19 spread: WHO (Reuters)
  • The world will need more than one COVID-19 vaccine, GSK CEO says (Reuters) (Endpoints)
  • WHO tasks ex-GSK CEO Witty with hastening COVID-19 vaccine R&D (Fierce) (Endpoints)
  • Fujifilm says significantly boosts capacity for COVID-19 treatment Avigan (Reuters)
  • India agrees to sell hydroxychloroquine to Malaysia to help fight COVID-19 (Reuters)
  • Gilead Launches PIII Remdesivir Trials for COVID-19 in Japan (PharmaJapan)
  • MHLW asks drugmakers, wholesalers to reduce staff coming to work by 70%” (PharmaJapan)
  • Kyowa Kirin pays $100m upfront for MEI’s blood cancer drug (PMLive) (PharmaJapan)
Coronavirus Pandemic
  • Data reporting frustrations peak (Politico)
  • Coronavirus Tests Science’s Need for Speed Limits (NYTimes)
  • Search for a COVID-19 vaccine heats up in China, US (AP)
  • J&J can produce up to 900 million coronavirus vaccine doses by April 2021 if trials go well (CNBC)
  • Coronavirus Survivors Hope for Immunity — The Reality Is More Complicated (Bloomberg)
  • Emails show US officials brushed off state concerns on drive-through virus tests (Reuters)
  • Trump announces ventilator loan plan to fight virus (Reuters)
  • We’ll see more shortages of diagnostic tests if the FDA has its way (STAT)
  • No evidence yet for effective COVID-19 treatments, review shows (ABC)
  • Hyped Malaria Pill Doesn’t Help Clear Coronavirus in Study (Bloomberg)
  • US clinical trials of hydroxychloroquine hit ‘warp speed,’ could show in weeks whether it works on coronavirus (CNBC)
  • General Motors says will make 1.5 million masks a month in Mexico (Reuters)
  • A Desperate Scramble As COVID-19 Families Vie For Access To Plasma Therapy (KHN)
  • Head lice drug emerges as potential coronavirus treatment, studies show (ABC)
  • MLB Employees Become the Subjects of a Huge Coronavirus Study (NYTimes)
  • Commission on Human Medicines advice on ibuprofen and coronavirus (COVID-19) (MHRA)
  • Athersys pivots a stem cell therapy to Covid-19, but prior data offer little confidence (STAT)
  • Projecting the transmission dynamics of SARS-CoV-2 through the postpandemic period (Science)
  • Bats are a key source of human viruses — but they’re not special (Nature)
  • U.S. military says coronavirus likely occurred naturally but not certain (Reuters)
  • US coronavirus deaths set single-day record increase: Reuters tally (Reuters)
  • NYC death toll rises to 10,000 as city includes untested coronavirus fatalities (Reuters)
  • California Gov. Gavin Newsom unveils guide to lifting state’s coronavirus restrictions (CNBC)
  • Japan health ministry projects 400,000 deaths without virus containment measures: media (Reuters)
  • China launches coronavirus survey in nine regions: state media (Reuters)
  • France's rate of coronavirus infections, deaths accelerating again (Reuters)
  • Coronavirus (COVID-19) Update: Daily Roundup April 14, 2020 (FDA)
Pharma & Biotech
  • FDA new drug approvals in Q1 2020 (Nature)
  • The top 10 drugs by sales increase in 2020 (Fierce)
  • Gene Therapies: ‘Trivial’ Changes Will Not Be Rewarded With Orphan Drug Designation And Exclusivity (Pink Sheet)
  • US FDA Coronavirus Response Features Three-Step Triage Process For Inquiries (Pink Sheet)
  • Repurposing drugs might help fight this pandemic (MIT Technology Review)
  • Supercomputers Help Researchers Speed Drug Discovery for Covid-19 (WSJ)
  • Virtual Advisory Committees Are Coming: US FDA Panels Will Be Smaller, More Focused (Pink Sheet)
  • How Some Manufacturers Are Navigating COVID-19 Pharma Supply Chain Challenges (Pink Sheet)
  • One of the best connected biotech startups in Boston snags a plum discovery deal with Novartis (Endpoints)
  • LEO Pharma mounts another challenge to the eczema giants, betting $40M cash on a drug from China (Endpoints)
  • Molecule-in-21-days AI startup Insilico adds Boehringer to list of Big Pharma partners (Endpoints)
  • The newest, $86M Third Rock startup chases the tiny biological machines inside of you (Endpoints)
  • FORMA Therapeutics Receives FDA Orphan Drug Designation for FT-4202 for the Treatment of Sickle Cell Disease (Press)
  • Small scale pharmas in Haridwar stop manufacturing hydroxychloroquine as price of raw material increases exponentially (Economic Times)
Medtech
  • Device to wean COVID-19 patients off ventilators gains EUA (MedtechDive)
  • CMS removes ventilators from DME bidding program due to high coronavirus demand (MedtechDive)
  • UK Updates Ventilator Specification Document As COVID-19 Patients Don’t Respond As Expected (Medtech Insight)
  • Kromek to make ventilators under licence from Japan's Metran (Reuters)
  • Philips debuts smaller emergency ventilator amid manufacturing expansion (Fierce)
  • COVID-19 in Europe: Postponed and remote Notified Body audits for medical device manufacturers (Emergo)
  • Illumina Announces Preliminary Q1 Revenues of $858M, Withdraws Guidance (GenomeWeb)
  • Quest rolls out furloughs, pay cuts amid low test volumes (Modern Healthcare)
  • New Frontier: COVID-19 Crisis Opens Door For Dexcom, Abbott To Bring CGMs Into Hospitals For First Time (Medtech Insight)
Government & Regulatory
  • Trump's new legacy: government expander-in-chief (Politico)
  • Health Canada responds to COVID-19 emergency (Emergo)
  • Amgen v. Sanofi Praulent® Litigation Once Again on Appeal before the Federal Circuit (Big Molecule Watch)
  • Minnesota Legislature passes emergency insulin bill after 'long and arduous road' (StarTribune)
  • CVC Reply No. 2 to Broad's Opposition No. 2 to CVC's Motion No. 2 to Be Accorded Benefit of Priority (Patent Docs)
  • Ex-Theranos CEO Seeks 2021 Trial After New Charges Emerge (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.

A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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