Regulatory Focus™ > News Articles > 2020 > 5 > Recon: FDA approves Lilly’s Retevmo for thyroid, lung cancers; China approves Novartis’ MS drug Mayz

Posted 11 May 2020 | By Michael Mezher 

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

2890 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
Sponsored Content: Clinical and regulatory challenges for cell and gene therapies
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government & Regulatory
  • 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)
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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