rf-fullcolor.png

 

March 9, 2020
by Michael Mezher

Recon: EU Leaders to Hold Emergency Coronavirus Meeting; BMS’ Empliciti Combo Fails in Phase 3 Multiple Myeloma Study

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • White House plays down US coronavirus concerns; stock markets plunge (Reuters)
  • Inside Trump Administration, Debate Raged Over What to Tell Public (NYTimes)
  • Trump's focus on coronavirus numbers could backfire, health experts say (Reuters)
  • Senator Cruz, Rep. Gosar self-quarantine after contact with coronavirus carrier (Reuters) (Politico)
  • Anxiety over coronavirus grows on Capitol Hill (The Hill) (NBC)
  • FDA head says 2.1 million coronavirus tests will have been shipped to labs by Monday (Reuters) (Statement)
  • Inside a coronavirus drug delay (Axios)
  • US excludes Chinese face masks, medical gear from tariffs as coronavirus spreads (Reuters)
  • New Trump rules aim to fuel sharing of patient health records by smartphone (STAT) (HealthcareDive) (FTC)
  • FDA approves ex-Novartis drug for Cushing’s disease (Endpoints) (FDA)
  • Bristol-Myers' multiple myeloma combo therapy fails study (Reuters) (Endpoints) (Press)
  • Roche Loses Bid to Block Amgen’s Biosimilar of Herceptin (Bloomberg) (Big Molecule Watch)
In Focus: International
  • EU leaders set to hold emergency talks over coronavirus (Reuters)
  • First coronavirus case detected at EU Commission (Reuters)
  • Covid-19 outbreak: Indian Pharma companies airlift inputs to deal with supply disruptions (Economic Times)
  • Neil Woodford in the game to buy back his former unlisted portfolio that's proving hard to sell — reports (Endpoints)
  • Biopharma stocks take a beating as economic turmoil takes its toll — but some players with coronavirus efforts underway are up (Endpoints)
  • GSK's ViiV touts 2-month HIV data as sister injection Cabenuva awaits FDA redemption (Fierce) (Press)
  • NICE shoots down Dupixent for severe asthma (Pharmafile)
Coronavirus Outbreak
  • Track Reported Cases of COVID-19 (Johns Hopkins)
  • CDC warns against long plane trips and cruises as coronavirus cases mount (Politico)
  • In US, Cases of Coronavirus Cross 500, and Deaths Rise to 22 (NYTimes)
  • US Has Tested Fewer Than 6,000 Virus Samples , FDA Says (Bloomberg)
  • Iowa biotech firm says it has produced enough coronavirus tests for 700,000 patients (Des Moines Register)
  • US Department of Health and Human Services calls for coronavirus product proposals (PMLive) (HHS)
  • Surging Health Care Worker Quarantines Raise Concerns As Coronavirus Spreads (KHN)
  • Dozens of health screeners at LAX ordered to self-quarantine: US official (Reuters)
  • Takeda, drug maker with biggest head count in Mass., tells most employees to work from home (Boston Globe) (Endpoints)
  • Top Biogen execs were present at meeting where attendees had Covid-19 (STAT) (Endpoints)
  • BioCentury survey finds action lags concern about the business impact of COVID-19 (BioCentury)
  • ACC scraps its flagship event in Chicago as Covid-19 fears spread faster than the virus (Endpoints)
  • China May Be Beating the Coronavirus, at a Painful Cost (NYTimes)
  • China reports no new locally transmitted coronavirus cases outside epicenter (Reuters)
  • Under fire over virus, Japan's Abe may seek emergency declaration (Reuters)
  • South Korea sees coronavirus 'stable phase' but 'too early to be optimistic' (Reuters)
  • Philippines to declare health emergency after first community transmission of coronavirus (Reuters)
  • Indonesia confirms 13 more people infected with coronavirus, total 19 (Reuters)
  • Coronavirus: Northern Italy quarantines 16 million people (BBC) (NYTimes) (Reuters)
  • Italy's neighbors take steps to curb spread of coronavirus (Reuters)
  • France records more than 1,000 coronavirus cases, death toll rises to 19 (France24)
  • UK discusses possible steps to stem coronavirus spread: PM Johnson's spokesman (Reuters)
  • Number of UK coronavirus cases rises by 30% to 273, third person dies (Reuters)
  • Swiss death toll from new coronavirus rises to two (Reuters)
  • Number of Dutch coronavirus infections rises to 321: health authorities (Reuters)
  • Moldova reports first coronavirus case (Reuters)
  • Bulgaria confirms first four cases of coronavirus: health officials (Reuters)
  • Maldives confirms first two coronavirus cases; two resort islands locked down (Reuters)
  • Albania confirms first coronavirus cases, in father and son back from Italy (Reuters)
  • Costa Rica raises coronavirus cases to nine, including three Americans (Reuters)
  • Argentina confirms first death in Latin America of patient with coronavirus (Reuters)
  • Colombia confirms its first case of coronavirus (Reuters)
  • Coronavirus kills 237 in Iran, 7,161 infected: Health Ministry (Reuters)
  • Iran temporarily releases 70,000 prisoners as coronavirus cases surge (Reuters)
  • Saudi Arabia reports four new coronavirus cases (Reuters)
  • Egypt reports first coronavirus fatality as German tourist dies (Reuters)
  • UAE reports 14 new coronavirus cases, tally reaches 59 (Reuters)
  • Australia ramps up epidemic preparation as third man dies of coronavirus (Reuters)
  • Grand Princess cruise ship passengers bound for coronavirus quarantine in California, elsewhere  (Reuters) (NPR)
  • Pace of medical conference shutdowns is accelerating as the coronavirus outbreak spreads (STAT)
  • Ex-FDA chief says US coronavirus financial bailout needed to help curb the rapidly spreading virus (CNBC) (The Hill)
  • People ‘shed’ high levels of coronavirus, study finds, but most are likely not infectious after recovery begins (STAT)
  • Haste plus speed: the need to ensure COVID-19 vaccines don’t make infections worse (BioCentury)
  • To develop a coronavirus vaccine, synthetic biologists try to outdo nature (STAT)
  • Avellino Labs Announces Availability of New FDA-Recognized Genetic Test for Coronavirus (Press)
  • Amazon removes hundreds of thousands of ‘high-priced offers’ amid coronavirus price gouging (CNBC)
  • EBay bans sales of all face masks and hand sanitizers to combat coronavirus price gouging (CNBC)
  • Surge of Virus Misinformation Stumps Facebook and Twitter (NYTimes)
Pharmaceuticals & Biotechnology
  • Amazon is secretly working on a cure for the common cold (CNBC)
  • Common antibiotics tied to miscarriages may also lead to birth defects (Reuters)
  • Heart association admits teaming with Bayer on drug-store aspirin displays was a ‘misstep’ (STAT)
  • Aspirin, the Original Wonder Drug (NYTimes)
  • Amgen Sees A Vibrant Biosimilars Market As Its Business Pushes Into Blockbuster Territory (Scrip-$)
  • Mitsubishi joins Eisai, 3SBio's bet on multispecific antibodies, upping Numab's Series B haul to $23M+ (Endpoints)
  • Trifecta of clinical stage biotechs unveil IPO plans, braving Wall Street's coronavirus panic (Endpoints)
  • With positive key trial, Kala Pharma's dry eye drug Eysuvis emulates approval path set by Xiidra (Endpoints)
  • Chinese biotech bags $58M for I/O, autoimmune work, starting with ALK5 inhibitor (Endpoints)
  • Inovio files for $50 million offering amid Covid-19 vaccine hunt; Zydus Cadila signs on with XOMA on IL-2 deal (Endpoints)
  • When it comes to opioids, it’s all about turf. (Harvard Bill of Health)
  • Vasella helps Numab to CHF22M round ahead of cancer trial start (Fierce)
  • The need for evolution in pharmacovigilance (Pharmafile)
  • Centre for Innovation in Regulatory Science awarded $1.09m Gates Foundation grant (PMLive)
  • AbbVie, Lilly, Pfizer lead pharma TV spending to roaring start in 2020 (Fierce)
  • Predicting novel antibacterial agents (Nature)
  • Targeting CAR T cells to glioblastoma (Nature)
  • Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension Usp, 125 Mg/5 Ml due to Possible Underdosing or Overdosing (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Uganda finalising clinical trials on new injectable HIV drug (Pharmafile)
  • US FDA accepts Biocon's cancer drug application for review (Economic Times)
  • AVROBIO Receives Orphan Drug Designation from U.S. FDA for AVR‑RD‑04 for Cystinosis (Press)
  • FSD Pharma Begins Phase 1 In-human Safety and Tolerability Study of Ultra Micro-Palmitolylethanolamide (PEA) (Press)
Medical Devices
  • Johnson & Johnson, Apple’s New Virtual Trial Model Shows Early Enrollment Success (Forbes)
  • Pavmed to resubmit carpal tunnel device 510(k) application (MassDevice)
  • NeuroPace wins FDA approval of MRI labeling for its neurostim system (MassDevice) (Press)
US: Assorted & Government
  • Justices Reverse Alito’s Partial Stay Of Generics Discovery (Law360-$)
  • Assertio, Lupin, Bausch Must Face Buyers' Price-Fixing Suit (Law360-$)
  • J&J Escapes Suit After Couple Can't ID Pelvic Mesh Maker (Law360-$) (MassDevice)
  • AARP, Consumer Groups Back Calif. Pay-For-Delay Ban (Law360-$)
  • FDA Focus: What King & Spalding's Practice Head Is Watching (Law360-$)
  • Court Determines that Decade’s Worth of Missing Data Must Be Published on ClinicalTrials.gov but Enforcement of Reporting Violations Hinges on FDA Discretion (FDA Law Blog)
  • USPTO Issues Clarification Regarding Petitions Based on Unintentional Delay (Patent Docs)
  • Attorney General William P. Barr Delivers Remarks at the Department of Justice's 2020 National Opioid Summit (DOJ)
Upcoming Meetings & Events Europe
  • EMA Unveils Revamped Human Medicines Unit (Pink Sheet-$)
  • Territorial Limits to Pro-Plaintiff Member State Law Likely To Be OKed In EU (Drug & Device Law)
General Health & Other Interesting Articles
  • The ‘London Patient,’ Cured of HIV, Reveals his Identity (NYTimes)
  • Shift in colorectal cancer diagnoses, deaths to younger patients (Reuters)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.