Recon: FDA rejects Merck’s chronic cough drug, Pfizer-OPKO growth hormone deficiency treatment; EMA expected to decide on Pfizer COVID pill by end of January

• Califf on Path to Win FDA Chief Role Despite Expected ‘No’ Votes (Bloomberg)
• FDA approves use of antiviral drug remdesivir as an outpatient therapy for people with covid-19 (Washington Post) (BioPharma Dive)
• Merck drug for chronic cough rejected by FDA (BioPharma Dive) (Reuters) (Endpoints)
• FDA expected to sharply restrict use of two monoclonal antibodies, spurring a halt in federal shipments of the covid-19 treatments (Washington Post) (Reuters)
• Lab study shows omicron-blocking antibodies persist four months after a Pfizer-BioNTech booster (Washington Post)
• FDA declines to approve Pfizer-OPKO growth hormone deficiency treatment (Reuters) (Endpoints)
• US FDA’s New Drug Median Review Time Held Steady At Eight Months In 2021 (Pink Sheet)
• FBI searches headquarters of embattled COVID testing lab (The Hill)
• ‘The CDC alone can’t fix this’: Walensky calls for overhaul of US public health system  (Politico)
• Accutane Scripts Stalled for Weeks After Safety System Revamp (Bloomberg)
• Failing to confirm clinical benefit, Gilead pulls 2 accelerated approval indications for cancer drug (Endpoints)

• EU regulator set to rule on Pfizer COVID pill by end-Jan, ahead of Merck (Reuters)
• Advocacy group urges Pfizer to sell more COVID pills to developing countries (Reuters)
• Sinovac regimen gets strong boost from Pfizer, AstraZeneca or J&J COVID shots – study (Reuters)
• European Medicines Agency panel approves scaling up AstraZeneca COVID vaccine production (Reuters)
• Pharma Heads Hope Trust Built Through Pandemic With Policymakers Will Last (Scrip)
• Lupin’s Foncoo Partnership Beginning Of China Challenge To AZ, Cipla? (Scrip)

• Omicron’s Spread Could End ‘Emergency Phase’ of Pandemic, Top W.H.O. Official Says (NYT)
• Do not assume COVID pandemic reaching 'end game', warns WHO (Reuters)
• Pfizer CEO sees annual COVID vaccine rather than frequent boosters (Reuters)
• US cases ‘going in the right direction,’ Fauci says (Washington Post)
• Beijing 2022 eases COVID curbs for Games; China warns on pollution (Reuters)
• Japan to widen COVID curbs amid Omicron surge (Reuters)
• Russia reports record daily COVID-19 cases (Reuters)

• Time limits on accelerated approvals? FDA's oncology chief Rick Pazdur eyes potential reforms via international approaches (Endpoints)
• Medicare’s Final Coverage Decision On Alzheimer’s Drugs: Thoughts From A Former CMS Chief (Pink Sheet)
• Roche sees cause for optimism with failed Huntington's disease drug. Others aren't so sure. (BioPharma Dive)
• Alnylam, awaiting key study data, builds case for its next rare disease drug (BioPharma Dive)
• Eli Casdin co-leads $250M infusion into microfluidics player that landed NIH funding for Covid-19 testing (Endpoints)
• Months after pulling only drug from US, Oncopeptides takes back withdrawal request -- but stays mum on why (Endpoints)
• A new nonprofit wants to design cheap drug trials, aiming to build on massively successful Covid-19 study (Endpoints)

• European Commission’s 2022 Schedule: Major Focus On Eudamed Database (MedTech Intelligence)
• Medtech earnings season shows bumpy end to 2021 for some, bonanza for others (MedTech Dive)
• Philips targets Q4 2022 end to recall as supply chain issues drag down results (MedTech Dive)
• Medtronic's HawkOne recall labeled Class I, adding to medtech's product safety problems (MedTech Dive)
• Boston Scientific, Sterigenics start tracking ethylene oxide emissions under new EPA rules (MedTech Dive)

• DOJ's dismissal of whistleblower's fraud case against drugmakers upheld (Reuters)
• Florida man convicted of falsifying clinical trial results sentenced to over 2 years in prison (Endpoints)
• Critics push back on Alzheimer’s Association ad blitz to get Medicare to change its Aduhelm ruling: 'Dead wrong' (Endpoints)
• Texas Judge Blocks Vaccine Mandate For Federal Workers (Law360)