Recon: FDA approves Lilly’s Retevmo for thyroid, lung cancers; China approves Novartis’ MS drug Mayzent

• Three key US coronavirus officials in self-quarantine after COVID-19 exposure (Reuters)
• Pence not in quarantine, to be at White House Monday, after aide tests positive for coronavirus (Reuters)
• Why the US isn't prepared to meet overwhelming demand for coronavirus vaccine (Politico) (NBC)
• Pfizer to outsource some drug production, focus on coronavirus vaccine (Reuters)
• NIH begins study of remdesivir with anti-inflammatory drug to treat COVID-19 (Reuters)
• Former NIH chief favored as Trump’s ‘therapeutics czar’ (Politico)
• Federal watchdog backs reinstating ousted vaccine expert (Politico)
• Study suggests Abbott COVID-19 antibody test highly likely to give correct results (Reuters)
• FDA grants emergency use authorization to Abbott Labs’ new coronavirus antibody test (CNBC)
• Iran-linked hackers recently targeted coronavirus drugmaker Gilead – sources (Reuters)
• 14 questions for Fauci, Redfield, and other officials testifying on US coronavirus response (STAT)
• FDA approves Eli Lilly drug for thyroid, lung cancers driven by a genetic mutations (Reuters) (Endpoints) (FDA) (Press)

• Triple antiviral drug shows early promise in COVID-19 trial (Reuters) (NYTimes)
• WHO conditionally backs Covid-19 vaccine trials that infect people (The Guardian) (Financial Times)
• Countries must return to public health surveillance in COVID-19 fight: WHO's Ryan (Reuters)
• WHO readies coronavirus app for checking symptoms, possibly contact tracing (Reuters)
• Drug manufacturing must be brought to UK, NHS bosses and charities tell MPs (The Guardian)
• Chinese drugmaker in talks to test virus vaccine globally (Economic Times)
• China approves Novartis' multiple sclerosis treatment Mayzent (Reuters)
• China's health authority to tighten rules on laboratory controls (Reuters)
• China to reform disease prevention system (Reuters)
• Japan to extend foreign investment controls to Avigan suppliers: Yomiuri (Reuters)
• Takeda’s Entyvio SC Form Approved in Europe (PharmaJapan)
• UK reopens recruitment campaign for MHRA chair (MHRA)

• Inside the NIH’s controversial decision to stop its big remdesivir study (STAT)
• Trump administration announces plan to distribute Covid-19 drug amid concerns over allocation (STAT) (Reuters)
• Haphazard Rollout of Coronavirus Drug Frustrates Doctors (NYTimes)
• A Much-Hyped COVID-19 Drug Is Almost Identical to a Black-Market Cat Cure (The Atlantic)
• COVID Survivors’ Blood Plasma Is A Sought-After New Commodity (KHN)
• Univ. of Tokyo Starts Testing Avigan Plus Futhan for COVID-19 (PharmaJapan)
• COVID-19 Phase III Trial Design: Big Ambitions, Little Consistency (Pink Sheet)
• Rare syndrome tied to COVID-19 kills three children in New York, Cuomo says (Reuters)
• China's Wuhan reports first coronavirus cluster since lifting lockdown (Reuters) (Reuters)
• South Korea's Moon warns of COVID-19 second wave as cases rebound (Reuters)
• Coronavirus: French doctors find man who may be Europe's 'patient zero' (NBC)
• Russian coronavirus cases above 200,000 (Reuters)
• Coronavirus cases in Gulf Arab region surpass 100,000 (Reuters)
• Lebanon fears second coronavirus wave as new infections surge (Reuters)
• Coronavirus (COVID-19) Update: Daily Roundup May 8, 2020 (FDA)

• Results indicate MyoKardia drug is a ‘potential game changer’ for heart condition (STAT) (Endpoints)
• Astrazeneca Says Lynparza Gets Broader U.S. Ovarian Cancer Approval (Reuters) (Endpoints) (PharmaTimes)
• A new Trump administration rule could increase out-of-pocket drug costs (STAT)
• COVID-19 Drug Shortages: EU Explores Tweaking National Forecasting Models (Pink Sheet)
• Generic Drug Bioequivalence Study Interruptions Not Just A Coronavirus Problem (Pink Sheet)
• STADA and Xbrane Ink Commercialization Deal with Bausch + Lomb for LUCENTIS Biosimilar Candidate (Big Molecule Watch)
• Fritz Gerber, who led Roche for 2 decades, dies; ADC Therapeutics tries again for an IPO, sets terms (Endpoints)
• Small biotech Oyster Point sets up pitch to disrupt dry eye market with nasal spray (Endpoints)
• Bluebird takes $200M payout from Bristol Myers as Covid-19, BLA delays force execs to bring out the budget ax (Endpoints)
• Derailed by the pandemic, FDA offers CRISPR, Vertex drug program VIP status for its comeback play (Endpoints) (Press)
• Spun out of George Church's lab, this biotech upstart is mapping the AAV universe for Novartis, Sarepta to gaze (Endpoints)
• Top Genentech researcher steps away and Roche turns to the Broad for a star replacement player (Endpoints)
• ENHERTU® Granted Breakthrough Therapy Designation in the U.S. for HER2 Positive Metastatic Gastric Cancer (Press)
• Higher investigational doses of Trulicity® (dulaglutide) meaningfully reduced A1C and body weight in people with type 2 diabetes (Press)

• Why The EU Urgently Needs A One-Year Delay For The IVDR And EU-Wide Exceptions For IVDs (MedtechInsight)
• FDA publishes first validation results of 12 COVID-19 antibody tests (Fierce)
• Zimmer Biomet loses $509m in Q1, expects significant negative impact in Q2 (MassDevice)
• Cardinal Health up on Street-beating Q3 results (MassDevice)

• PRAC recommendations on signals (EMA)
• On Newly Acquired Information (Drug & Device Law)
• Virus Collaborations Could Create Messy Patent Questions (Bloomberg Law)
• US Trade Representative Releases 2020 Special 301 Report (Patent Docs)
• Pharma Cos. Escape Claims Drugs Caused Painful Disease (Law360)
• Apotex Seeks To Revive Hospira Unfair Competition Fight (Law360)