Recon: Purdue pleads guilty to criminal charges; EMA hopeful it can recommend COVID vaccine in December

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

• OxyContin maker Purdue Pharma pleads guilty to criminal charges (Reuters) (AP) (NYTimes) (DoJ )
• House committee wants Purdue CEO and Sackler family members to testify at opioid crisis hearing (STAT)
• Pfizer's Coronavirus Vaccine Supply Contract Excludes Many Taxpayer Protections (NPR)
• Azar says states will decide who gets first Covid-19 shots (Politico)
• US officials plan to release 6.4 million COVID-19 vaccine doses in first distribution (Reuters)
• US to test run Covid vaccine distribution networks as it awaits FDA clearance in ‘just a few weeks’ (CNBC)
• Which pricey drugs will Trump’s international pricing policy target? (STAT)
• Urovant's lead drug disappoints in mid-stage study as first big FDA decision looms (Endpoints)

In Focus: International

• EU drug regulator 'very hopeful' can endorse COVID-19 vaccine by Christmas (Reuters)
• EU seeks fast-track bypassing of pharma patents in emergencies (Reuters)
• China Vaccine Maker Applies for Public Use of Covid Shot (Bloomberg)
• Recipharm to produce some of Moderna's COVID-19 vaccine in France (Reuters)
• BioNTech, Fosun start Phase II trial of COVID-19 vaccine in China (Reuters)
• Mexico aiming to start COVID-19 vaccinations in December (Reuters)
• Eli Lilly to supply 26,000 doses of COVID-19 antibody drug to Canada (Reuters)

Coronavirus Pandemic

• FDA clears a ‘new generation’ of Covid antibody test designed to tell how well someone is protected against the virus (CNBC)
• Mutations not making coronavirus able to spread more rapidly -study (Reuters)
• Evidence Builds That an Early Mutation Made the Pandemic Harder to Stop (NYTimes)
• Covaxx inks supply deals worth $2.8B in lead-up to coronavirus vaccine midstage trials (Fierce)
• CDC to shorten length of quarantine for those exposed to Covid-19 (NBC)
• Plasma from recovered patients shows little benefit in those hospitalized with COVID-19: study (Reuters)

Pharma & Biotech

• How Joe Biden Will Change The FDA: Part 2 (Law360)
• ‘The trend is irreversible’: How Covid-19 could drive a shift toward decentralized trials (STAT)
• US FDA’s 2020 User Fee Calendar Still Holds Promise Of Merry Novel Approval Count (Pink Sheet)
• Continued Advancement of ICH’s Global Public Health Mission 30 Years On (ICH)
• BMS inks drug discovery deal with Schrödinger (PharmaTimes)
• After Kodak debacle, US lends $1.1B to a synthetic biology company and their big Covid-19, mRNA plans (Endpoints)
• FDA hands Liquidia and Revance a CRL and deferral, respectively, as Covid-19 creates inspection challenge (Endpoints)
• News briefing: FDA requests new trial for Reata's Friedreich's ataxia program; J&J's Tremfya picks up expanded label in Europe (Endpoints)
• China opens the door for biotech investors in Hong Kong to buy Shanghai stocks, and vice versa (Endpoints)
• ABPI warns that no-deal Brexit could disrupt medicines and vaccine delivery (Pharmafile)
• EU Clinical Trial Portal Requires Rethink On Balancing Business Interests & Transparency (Pink Sheet)
• UK Antitrust Arm Mulling Bipolar Drug Co.'s Commitments (Law360)

Medtech

• Breast cancer tech among FDA's latest breakthrough nods (MedtechDive)
• Medtronic details diabetes, TAVR offensives as COVID-19 recovery progresses (MedtechDive)
• Medical device patient information leaflets and implant cards (TGA)
• Experts: HHS Review Proposal May Free Industry From Regulatory Red Tape (MedtechInsight)
• Mexican regulators set aggressive new deadlines for medical device equivalency route approvals (Emergo)
• EC publishes IVDR classification rules and draft standardization request (Emergo)

Government, Regulatory & Legal

• Ferring B.V. v. Allergan, Inc. (Fed. Cir. 2020) (Patent Docs)

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.