Recon: Sinovac vaccine trial halted in Brazil; Amgen, AstraZeneca asthma drug hits Phase 3 goals

• Asthma drug from Amgen, AstraZeneca achieves main goals in late-stage clinical trial (STAT) (Endpoints)
• Two conservative US Supreme Court justices suggest Obamacare may not be thrown out (Reuters)
• Health Secretary Azar says US has a plan to start Pfizer vaccine shots in December: CNBC (Reuters)
• Arcturus expects its COVID-19 vaccine to be ready by first-quarter 2021 (Reuters)
• Inovio expects FDA decision on COVID-19 vaccine trial start this month (Reuters)
• Eli Lilly’s Antibody Treatment Gets Emergency FDA Approval (NYTimes) (Politico) (FT)
• U.S. denounces terms for WHO-led inquiry into COVID origins (Reuters)

• EU to approve Pfizer COVID vaccine contract on Wednesday (Reuters)
• BioNTech to price vaccine below market rates, differentiate between regions (Reuters)
• Medicago's COVID-19 vaccine triggers immune response in early-stage trial (Reuters)
• Janssen, Novavax plan Mexican late stage COVID-19 vaccine trials, minister says (Reuters)
• UK vaccine chief to step down at year-end, Hancock says (Reuters)
• Covid: China's Sinovac vaccine trial halted in Brazil (BBC) (FT)

• US coronavirus cases top 10 million (Politico)
• Pfizer’s Covid Vaccine: 11 Things You Need to Know (NYTimes)
• Does a vaccine against Covid-19 herald the end of the pandemic (FT)
• Drug companies deliver a vote of confidence in adaptive trial for Covid-19 (STAT)
• Make pre-approval Covid-19 vaccines available through expanded access, not an EUA (STAT)
• Why Pfizer’s ultra-cold COVID-19 vaccine will not be at the local pharmacy any time soon (Reuters)
• Italy expects to get 3.4 million doses of Pfizer vaccine in January: government source (Reuters)
• Spain hopes to receive first Pfizer vaccines in early 2021 (Reuters)
• Pfizer COVID-19 vaccine "very promising" but cold chain issues – WHO (Reuters)
• How Pfizer vaccine could be cold comfort for some Asian nations (Reuters)
• Croda strikes deal with Pfizer to supply COVID-19 vaccine additives (Reuters)
• Oxford ups COVID-19 testing capacity with Thermo Fisher deal (Reuters)

• ViiV’s HIV prevention shot beats Gilead’s widely used pill in a study of women (STAT)
• Pharma Giants Market Their Value as Pandemic Bolsters Reputation (WSJ)
• Pfizer invests in Homology and adds to its gene therapy ambitions (BioPharmaDive)
• A few months after emerging from stealth, Praxis is handed a clinical hold for lead depression drug (Endpoints)
• Scientists criticize use of unproven COVID drugs in India (Nature)
• NICE recommends venetoclax combo, a non-chemo option for untreated chronic lymphocytic leukaemia (Pharmafile)
• EU OK for AZ’s Calquence in CLL (PharmaTimes)
• Waylivra, Tecentriq and more accepted by SMC (PharmaTimes)
• Scottish Medicines Consortium greenlights Nubeqa for prostate cancer (Pharmafile)
• US FDA Aims For More Timely Reviews Of Rx Drug Launch Promotions (Pink Sheet)
• DSMB hits pause on Voyager's Neurocrine-partnered Parkinson's gene therapy (Endpoints)
• FDA hits Supernus with double whammy, handing biotech a CRL and RTF on same day (Endpoints)
• Merck pulls the plug on a study evaluating blockbuster Keytruda with Yervoy for NSCLC (Endpoints)
• 'We're not a vant': Axovant seeks to forget the past as the company rebrands to Sio Gene Therapies (Endpoints)
• Vivek Ramaswamy eyes an I/O vant with up to $2B licensing deal (Endpoints)
• Arena's lead drug misses on PhII in AD, thwacking stock, but company soldiers on into Phase III (Endpoints)
• Industry Gets Breathing Space For Post-Brexit Regulation In Northern Ireland (Pink Sheet)
• USP’s Global Efforts to Strengthen Standards and Accelerate Innovation for Biologics Include ICH Engagement (IPQ)
• Isotretinoin and suspected link with serious side effects: public and patients’ views sought (MHRA)
• Sponsors advised of transition to eCTD-only (TGA)
• Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination (FDA)

• FDA clears Apple Watch sleep app that intervenes to stop nightmares caused by PTSD (Fierce)
• 50 Days To Brexit – And No Extension, Govt Warns UK Medtechs (MedtechInsight)
• Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use (FDA)

• PharmaMar Victory Has EU Regulators Pondering Next Move (Pink Sheet)
• AbbVie Takes Takeda To Chancery Over Lupron Shortfall (Law360)
• Illumina Says Rival Infringes DNA Sequencing IP At Trial Start (Law360)
• Biosimilars Caught In Crosshairs Of Supreme Court ACA Fight (Law360)