Recon: FDA approves Alnylam’s Oxlumo for PH1; EU secures 160M doses of Moderna vaccine

In Focus: US

• Alnylam wins US approval for its third rare disease drug (BioPharmaDive ) (FDA)
• Vaccinating a nation: can Biden manage America’s biggest health project? (FT)
• A Revamped Strategic National Stockpile Still Can't Match The Pandemic's Latest Surge (NPR)
• Amgen cuts Cytokinetics loose after heart drug disappointment (BioPharmaDive )
• A top Democrat on the House antitrust panel sets sights on Big Pharma after wrapping up tech probe (CNBC)
• PhRMA sues Trump government over drug importation rule — days before it's set to be effective (Endpoints)

In Focus: International

• EU drug regulator could rule on COVID-19 vaccines by year end (Reuters)
• EU secures 160 million doses of Moderna's COVID-19 vaccine (Reuters)
• Dosing error turns into lucky punch for AstraZeneca and Oxford (Reuters)
• AstraZeneca must prove it won't profit from COVID-19 vaccine - MSF (Reuters)
• Hundreds of millions of AstraZeneca vaccine doses secured -GAVI alliance (Reuters)
• Russia, eyeing foreign markets, says Sputnik COVID-19 vaccine to cost under $20 (Reuters) (CNBC)
• Brazil has enough infection data to analyze Sinovac's COVID-19 vaccine – officials (Reuters)
• Covid-19: World's top latex glove maker shuts factories (BBC)
• Novartis Plans $2.5 Billion Share Buyback as Pipeline Grows (Bloomberg)

Coronavirus Pandemic

• Remdesivir: the rise and fall of a Covid wonder drug (FT)
• Coronavirus vaccines face trust gap in Black and Latino communities, study finds (Washington Post)
• Ad Council’s Challenge: Persuade Skeptics to Believe in Covid Vaccines (NYTimes)
• Exclusive: South Africa confirms going for COVAX vaccine scheme for 10% of population (Reuters)
• Italy to get AstraZeneca COVID shots in early 2021, 70 million by mid-year (Reuters)
• As India readies vaccine strategy, Modi warns of possible side-effects (Reuters)
• Sweden's Recipharm signs deal to package Moderna's COVID-19 vaccine (Reuters)
• MHLW to Evaluate Suspected Adverse Reactions to COVID-19 Vaccines More Frequently than Usual: Minister (PharmaJapan)
• Advice for developers of COVID-19 vaccines (MHRA)
• Ensuring predictability for interim orders relating to COVID-19: Notice to stakeholders (Health Canada)

Pharma & Biotech

• How Joe Biden Will Change The FDA: Part 1 (Law360)
• The aducanumab conundrum: The PhIII failed a clear regulatory standard, but no one is certain what that means anymore at the FDA (Endpoints)
• FDA approves new dosing option for AZ’s Imfinzi (PharmaTimes)
• NICE backs Braftovi for BRAF-positive colorectal cancer (PharmaTimes)
• Innovation-Friendly? Cases Indicate How Far China's Willing To Protect Patents (Pink Sheet)
• Why the United States-Mexico-Canada Agreement is Important to FDA (FDA)
• Sanofi’s meningococcal vaccine wins EU approval (PharmaTimes)
• Genmab axes an ADC development program after the data fail to impress (Endpoints)
• India's Aurolife under water with the FDA after chronic ceiling leaks imperil generics produced on site (Fierce)
• After 5 quiet years, a former Scripps spinout raises $200M and announces plans to try again at an IPO (Endpoints)
• Baxter BioPharma Solutions Announces $50 Million Investment to Expand Sterile Fill/Finish Manufacturing Site in Bloomington, Ind (Press)
• Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (Press)

Medtech

• FDA clears Baxter's virtually connected, in-home peritoneal dialysis system (Fierce)
• NEJM commentary calls for 510(k)s for OTC hearing aids after senators pan FDA delay to rule (MedtechDive)
• AliveCor gets FDA nod for suite of cardiac focused AI algorithms (MobiHealthNews)

Government, Regulatory & Legal

• Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021 (MHRA)
• No Manufacturer Liability for After Market Modifications (Drug & Device Law)
• Merck Again Denied In Bid To Arbitrate Vaccine Antitrust Suit (Law360)
• HHS Increasing IP License Transparency After GAO Rebuke (Law360)
• Feds Say No Privilege For Ex-Theranos CEO In Fraud Case (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.