Recon: Jazz to buy GW Pharma for $7.2B; GSK, CureVac partner on vaccine for COVID variants

• Biden and Drug Makers Look to Speed Coronavirus Vaccine Deliveries (NYTimes)
• Biden administration to begin shipping vaccine doses directly to pharmacies (Politico)
• States in the US are Pulling Back Vaccine Doses from Federal Program for Nursing Homes (NYTimes)
• Vaxart shares plunge 60% on concern that lackluster antibody response will hinder effectiveness of oral Covid vaccine (CNBC)
• As the FDA clears a flood of AI tools, missing data raise troubling questions on safety and fairness (STAT)
• BMS turns in PRV for supplemental indication on an old Celgene drug (Endpoints)
• Bristol Myers Gains Covid Antibody in Deal With Rockefeller (Bloomberg)
• Missouri lawmaker indicted for allegedly selling fake stem cell treatments for Covid-19 (NBC)
• FDA approves new indication for Adamas’ Gocovri in Parkinson’s disease (PMLive)
• Pfizer's new rare-disease meds Vyndaqel, Vyndamax reach blockbuster threshold despite pandemic hurdles (Fierce)

• Jazz Pharma to buy GW Pharma for $7.2B (Reuters) (WSJ) (STAT) (FT)
• J&J Raises EU Concern With Plan to Package Vaccines in US (Bloomberg)
• GSK, CureVac team up to develop vaccine against COVID-19 variants (Reuters) (STAT) (FT)
• Oxford finds COVID-19 shot 76% effective for 3 months after single dose (Reuters) (NYTimes) (FT)
• EU Chief Says She Was Responsible for Gaffe Over Vaccine Exports (Bloomberg)
• AstraZeneca, Oxford expect 'next generation' COVID-19 vaccine to tackle variants by autumn – executive (Reuters)
• Swiss delay AstraZeneca COVID vaccine approval, order more shots from others (Reuters)
• EU mistakenly leaves key parts of AstraZeneca Covid-19 contract unredacted, revealing costs and Soriot's 'best-effort' claim (Endpoints)
• New Zealand approves Pfizer-BioNTech vaccine, warns against nationalism (Reuters)
• South Korea approves import of Pfizer COVID-19 vaccines, minister says (Reuters)
• Singapore approves Moderna's COVID-19 vaccine in Asia first (Reuters)
• Sinopharm vaccine remained active against S.Africa variant, effect reduced - lab study (Reuters)
• UK asks EU for Brexit grace period extension to 2023, BBC reports (Reuters)

• WHO team probing COVID-19 visits Wuhan lab, meets 'Bat Woman' (Reuters) (NYTimes)
• African countries look beyond west for vaccines (FT)
• In the Vaccine Scramble, Cancer Patients Are Left Behind (NYTimes)
• Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson (STAT)
• Oxford vaccine gives good immune responses in elderly, trial chief says (Reuters)
• US FDA Vaccines Adcomm May Be Called To Review COVID-19 Vaccine Strain Changes (Pink Sheet)
• Burned by Low Reimbursements, Some Doctors Stop Testing for Covid (NYTimes)
• COVAX poised to issue vaccine distribition plan - GAVI, WHO (Reuters)
• China to provide 10 million vaccine doses to COVAX initiative (Reuters)
• WHO-led COVAX vaccine scheme agrees new supply deal with India's Serum (Reuters)
• India to supply 1.1 billion doses of COVID-19 vaccines to UNICEF (Economic Times)
• Japan Moves Up Vaccine Rollout Target to Mid-February, PAFSC Review on Feb. 12? (PharmaJapan)
• Bharat Biotech, Ocugen sign pact for supply of Covaxin to US market (Economic Times)
• Over 300 million Indians may have COVID-19 - source citing government study (Reuters)
• Dutch to roll out rapid breath tests for COVID-19 (Reuters)
• BD secures European approval for COVID-19 blood test to predict which patients may need a ventilator (Fierce)

• BioCryst climbs after FDA approval for Rapivab in infants (Seeking Alpha)
• Year-end earnings show turbulent times for Hal Barron's GlaxoSmithKline turnaround (Endpoints)
• GSK culls cancer, rare disease meds amid Q4 clear-out (Fierce) (Press)
• US FDA’s Three Review Speeds: Standard, Priority – And Oncology (Pink Sheet)
• Amgen slams the brakes on a clutch of cancer drugs as reality BiTEs (Fierce)
• Biogen tosses out Parkinson's hopeful cinpanemab, pays $75M for its syn (Fierce)
• PhRMA Prods Japan to Harness Power of RWD in Drug Development, Medical Care Evaluation (PharmaJapan)
• CDMO Catalent trumpets biologics windfall courtesy of COVID-19 (Fierce)
• UK Patients gain early access to Pfizer's atopic dermatitis drug (PharmaTimes)
• NICE green light for GSK's Nucala (PharmaTimes)
• Canada Eyes Reducing Reliance On Pricing As Sole Reward for Innovation (Pink Sheet)
• Health Canada Approves Celltrion’s Infliximab Biosimilar for Treatment of Rheumatoid Arthritis (Big Molecule Watch)
• Mutabilis receives CARB-X grant for 'nightmare bacteria' treatment; AbSci and Xyphos shake hands on discovery deal (Endpoints)
• Innovent and Lilly win second China OK for Tyvyt in frontline NSCLC, ramping up pressure on king Keytruda (Endpoints)
• Neurocrine axes Parkinson's collab with Voyager after safety issues, jeopardizing biotech's long-running centerpiece (Endpoints)
• Mads Krogsgaard Thomsen hands off CSO job at Novo Nordisk after a 30-year run, then pivots to CEO post at huge Novo Foundation (Endpoints)
• Roche and Genentech's latest AI collaborator raises $25M Series A to reinvent one of the oldest cancer targets (Endpoints)
• Biogen sweeps out a Parkinson’s drug on PhII failure as analysts raise alarms about projected revenue slide — despite assuming an aducanumab OK (Endpoints)
• After raising $465M, Kurt von Emster talks about money, biopharma and a new breed of investor: 'The rising tide is pushing everybody into this sector' (Endpoints)
• Amgen Reports Fourth Quarter And Full Year 2020 Financial Results (Press)
• AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results (Press)

• FDA names its first medical device cybersecurity director (Fierce)
• Asian Regulatory Discussions: ASEANMed Nations Make Device Progress Despite Pandemic (MedtechInsight)
• Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures (FDA)
• Virtual manufacturing of medical devices (MHRA)

• Europe's Beating Cancer Plan: A new EU approach to prevention, treatment and care (EC)
• Mylan Defeats EpiPen Antitrust Lawsuit Brought by Rival Sanofi (Bloomberg Law)
• FDA Warns Sites Over Malaria Drug COVID-19 Claims (Law360)
• Par Pharma Abusing FDA Process To Foil Rivals, Amneal Says (Law360)
• Biotech scandal drags on as the feds only score partial victory against execs charged with cooking the books (Endpoints) (Law360)
• Pharma firm loses patent suit to stop generic HIV drug (Irish Times)