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February 4, 2021
by Michael Mezher

Recon: McKinsey settles opioid claims for $573M; UK to study Pfizer, AstraZeneca COVID vaccine combo

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Opioid crisis haunts frontrunner for top job at US drugs regulator (FTv)
  • Merck chief Kenneth Frazier to retire this summer (FT) (STAT) (CNBC)
  • After a Rocky Start, Novavax Vaccine Could Be Here by Summer (NYTimesv)
  • 55.9 million doses of COVID-19 vaccines distributed, 33.8 million administered: U.S. CDC (Reuters)
  • Merck anti-baldness drug Propecia has long trail of suicide reports, records show (Reuters)
  • Amgen cuts 500 jobs, primarily in sales, as COVID-19 speeds shift to digital (Fierce) (Endpoints)
  • McKinsey Settles for $573 Million Over Role in Opioid Crisis (NYTimes) (STAT)
  • Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2020 (Press)
In Focus: International
  • EU drugs watchdog conducts COVID-19 vaccine, treatment collaboration program (Reuters)
  • Britain trial to test combining Pfizer and AstraZeneca vaccines in two-shot regimen (Reuters)
  • COVAX allocates first tranche of 330 million vaccine doses to poor countries (Reuters)
  • Brazil to allow emergency use of COVID-19 vaccines tested abroad (Reuters)
  • Cancer drugs binned because of Brexit red tape, MPs hear (The Guardian)
  • Roche reports solid results in 2020 (Press)
  • Takeda FY2020 Q3 Results (Press)
Coronavirus Pandemic
  • With a seductive number, AstraZeneca study fueled hopes that eclipsed its data (STAT)
  • Vaccine passports: path back to normality or problem in the making? (Reuters)
  • Britain has given 10 million people a first COVID-19 vaccine dose (Reuters)
  • Sputnik-AstraZeneca COVID-19 vaccine trials to start in Azerbaijan, MidEast (Reuters)
  • Australia to buy 10 million additional doses of Pfizer COVID-19 vaccine (Reuters)
  • China bat caves need exploring in search for COVID origins, WHO team member says (Reuters)
  • Palestinians receive first shipment of Russia's Sputnik V vaccine (Reuters)
  • North Korea to receive nearly 2 million AstraZeneca vaccine doses in H1 - interim report (Reuters)
  • Taiwan says to get share of 1.3 million vaccines via COVAX (Reuters)
  • Thailand to get vaccine from Asia after EU export control, minister says (Reuters)
  • India's Serum delays vaccines for private sale in Bangladesh; focus on state campaigns (Reuters)
  • When Pandemic Ends, EUA Recipients May Face Litigation And Enforcement Actions (Pink Sheet)
Pharma & Biotech
  • Over one-third of young adults misuse psychoactive medications, study says (CNN)
  • BioNTech fund pays €600m dividend on back of vaccine success (FT)
  • The most successful oncology drug portfolios of the past decade (Nature)
  • GDUFA III: US FDA Says Generic Drug Supplement Volume Could Require More Resources (Pink Sheet)
  • With $588M IPO, Sana leads wave of new biotechs going public (BioPharmaDive) (Endpoints)
  • Consultation: Repurposing of Prescription Medicines (TGA)
  • Novo Nordisk plots $1.3B in spending as it expands API production—and advances new oral meds (Fierce)
  • Pfizer bags rheumatoid arthritis rights to new immunotherapy class through deal with Imcyse (Fierce) (Endpoints)
  • Merck KGaA goes toe to toe with Novartis as FDA green-lights MET inhibitor (Endpoints)
  • Veracyte drops $600M to acquire cancer tester Decipher Biosciences (Fierce)
  • US FDA Drug Review Goals Should Be Faster In PDUFA VII, Industry Negotiators Propose (Pink Sheet)
  • Nitrosamine Concerns Spur Precautionary Testing Of Rifampicin In EU (Pink Sheet)
  • MHLW, Saudi Govt Sign Memo on Regulatory Harmonization; Japan-Listed Drugs to Get Priority Review (PharmaJapan)
  • China approves AstraZeneca's heart failure drug Forxiga (PharmaTimes)
  • Neurocine ends partnership with Voyager for Parkinson's gene therapy (BioPharmaDive)
  • Senior AbbVie liaison quits job to launch neuro startup, with sights set on ALS (Endpoints)
  • Prothena revives its former lead drug, aiming for a smaller population with more severe cases (Endpointsv)
  • Novo Nordisk Divides R&D, Expects More Late-Stage Studies In 2021 (Scrip)
  • Roche chops TNBC programs following PhIII flops, further dimming the spotlight on Array drug (Endpoints)
  • Apotex recalls 2 batches of blood-thinner injection after syringe mislabeling snafu (Endpoints)
  • Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)(FDA)
  • Biocon Biologics to provide cancer biosimilars to 30 countries in Africa, Asia (Economic Times)
Medtech
  • Google expands its health goals with new wellness features for Pixel phones (STAT)
  • 23andMe to go public via Richard Branson’s SPAC (STAT)
  • Boston Scientific sees COVID-19 electives pressure in Q1, recovery in second half (MedtechDive)
  • PerkinElmer predicts sharp falloff in COVID-19 sales this year (MedtechDive)
  • Quest says high demand for Covid testing drove record revenues, increases dividend (CNBC)
  • Death, injuries prompt FDA to call Boston Scientific ICD recall Class I event (MedtechDive)
  • Apple Watch can help track Parkinson’s disease symptoms, research shows (STAT)
  • Baxter Reports Fourth-Quarter and Full-Year 2020 Results (Press)
Government, Regulatory & Legal
  • Frontrunner emerges for Biden’s Medicare and Medicaid chief (Politico)
  • Bayer reaches $2 billion deal over future Roundup cancer claims (Reuters)
  • Pandemic Emergency Manufacturing Act Introduced In US Congress (MedtechInsight)
  • Teva Aims To Revoke IP For BMS Blockbuster Blood Thinner (Law360)
  • Challenging Therapeutics IP After Fed. Circ. Drink Can Ruling (Law360)
  • Covidien Tells Panel That Judge Garbled Patent Case Verdict (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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