Regulatory Focus™ > News Articles > 2019 > 3 > Recon: PTAB Rejects Bid to Challenge Celgene’s Revlimid Patent

Recon: PTAB Rejects Bid to Challenge Celgene’s Revlimid Patent

Posted 14 March 2019 | By Michael Mezher 

Recon: PTAB Rejects Bid to Challenge Celgene’s Revlimid Patent

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • US court rejects Alvogen's patent challenge for Celgene's cancer drug (Reuters) (Endpoints)
  • How the not-for-profit Civica Rx will disrupt the generic drug industry (STAT)
  • FDA faces test under new chief (The Hill)
  • A believer in biotech and big data: How Ned Sharpless vaulted to the top of the FDA (STAT)
  • Leading scientists, backed by NIH, call for a global moratorium on creating ‘CRISPR babies’ (STAT) (BuzzFeed) (Financial Times)
  • Akari skyrockets as FDA clears pivotal trial for dual-action Coversin in pediatric TMA (BioWorld)
  • HHS Secretary Azar defends Trump budget cuts to Medicaid, NIH programs (CNBC)
  • Insys may go out of business as controversy, fines, and lawsuits intensify (STAT) (Endpoints)
  • Everything we know about Haven, the Amazon joint venture to revamp health care (CNBC)
  • Amgen's top-selling Enbrel in balance as key court ruling nears (BioPharmaDive)
  • Merck Gets PTAB To Nix Patent On Pfizer Vaccine Prevnar 13 (Law360-$)
  • At a big cardiology meeting, glitzy tech will collide with sober science (STAT)
  • Special Report: Online activists are silencing us, scientists say (Reuters)
  • Parents Wanted Their Unvaccinated Children in School, but a Judge Said No. (NYTimes)
In Focus: International
  • Leading scientists, backed by NIH, call for a global moratorium on creating ‘CRISPR babies’ (STAT) (BuzzFeed) (Financial Times)
  • Novartis’ Sandoz chief is walking out in the middle of a global revamp, fueling fresh buzz about a spinoff (Endpoints) (Pharmafile) (Financial Times)
  • More Brexit chaos as government suffers more defeats (PMLive)
  • Ebola response is working, WHO director-general says, amid criticism and violence (STAT)
  • Merck notches fourth lung cancer approval in Europe for flagship Keytruda (Endpoints) (PharmaTimes)
  • Merck KGaA teams up with Iktos in drug discovery (Seeking Alpha) (Press)
  • Germany joins CARB-X, commits €40M to fighting bacteria (Fierce)
  • Novartis Strikes Kymriah Outcome-Based Deal With German Insurers (Pink Sheet-$)
  • UK breast cancer patients win early access to Tecentriq/nab-paclitaxel (PharmaTimes)
  • China Releases Timeline, Priority Diseases For Revised Reimbursement List (BioCentury)
  • Roche and Chugai's Hemlibra scoops up EU approval in the prevention of severe haemophilia A without factor VIII inhibitors (Pharmafile) (Press)
  • Interview: Head Of Turkish Industry Body Highlights Key Challenges In 2019 (Scrip-$)
  • Australian medical device regulators preparing Brexit contingency plans (Emergo)
Pharmaceuticals & Biotechnology
  • The fragmentation of biopharmaceutical innovation (Nature)
  • Overlooked inactive ingredients in pills can trigger allergic reactions, study finds (STAT)
  • Value extends beyond the cost of drugs and health care (STAT)
  • Trump's new FDA chief must wage fierce fight to stop the opioid epidemic. Gottlieb didn't. (USA Today)
  • C4 poaches new CMO after signing $900M clinical development deal with Roche (Fierce)
  • Scientists find new approach that shows promise for treating cystic fibrosis (NIH)
  • Lilly CEO David Ricks snags $17.2M pay package for 2018, a 9% hike (Fierce)
  • J&J chief Alex Gorsky suffers a big drop in compensation, but still comes out way ahead of most major league CEOs (Endpoints)
  • Esperion shares yo-yo as NEJM papers downplay cancer death data (Fierce)
  • CEO of biotech investor Hercules Capital abandons his post in the midst of a college cheating scandal (Endpoints)
  • Surrozen banks $50M round to fuel its drive to the clinic with regenerative med platform (Endpoints)
  • New insights emerge in an effort to repurpose Novartis’ cancer drug Tasigna in Parkinson’s disease (Fierce)
  • Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Alkahest to Present Results from Phase 2a Open Label Study of AKST4290 in wet AMD at Retina World Congress (Press)
  • Biohaven Enrolls First Patient In Phase 3 Spinocerebellar Ataxia Clinical Trial Of Troriluzole (Press)
  • Cannara Biotech Announces Expansion of Phase 1 Build-Out and Board of Directors Update (Press)
  • BioArctic Announces Start of Phase 1 Study of ABBV-0805 for Parkinson's Disease (Press)
Medical Devices
  • Stryker pays up to $220m for OrthoSpace (MassDevice)
  • FDA approves BD’s Venovo venous stent (MassDevice)
  • FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation (FDA)
  • The Next Generation of Watchman Just Received CE Mark (MDDI)
  • PGDx Liquid Biopsy Assay Gets CE Marking (GenomeWeb)
  • Medtronic Board Appoints Andrea J. Goldsmith, Ph.D. as a New Director (Press)
  • Class 1 Device Recall Cook Transseptal Needle (FDA)
  • Miach Orthopaedics touts results of two-year study on ACL repair (MassDevice)
US: Assorted & Government
  • Amid the opioid crisis, a different drug comes roaring back (Economist)
  • Medicaid work requirements get their day in court today (Politico)
  • CMS Updates Drug Dashboards with Prescription Drug Pricing and Spending Data (CMS)
  • Healthcare Reformers Should Look To Europe For Feasible Alternatives To Medicare For All (Forbes)
  • Johnson & Johnson Hit With $29 Million Verdict in California Talc Cancer Case (NYTimes)
  • Allergan Says It Needs Takeda Docs To Fend Off NJ Suit (Law360-$)
  • Taxing Drug Decision Goes Against Gambler (Drug & Device Law)
  • Owner of Washington, D.C.-Based Durable Medical Equipment Company Sentenced to Prison for Role in $9.8 Million Medicaid Fraud Scheme (DoJ)
  • Five Individuals and Two Companies Plead Guilty to Felony Charges in Multimillion Dollar Scheme to Fraudulently Sell Popular Dietary Supplements (DoJ)
  • Six Individuals and Two Companies Charged in Illegal Dietary Supplement Scheme (DoJ)
  • Philadelphia-Area Doctor Pleads Guilty to Unlawfully Distributing Oxycodone (DoJ)
  • Creator of Fraudulent Chicago-Area Pharmacy Sentenced to Five Years in Prison for $1.6 Million Fraud Scheme (DoJ)
Upcoming Meetings & Events
  • FDA Advisory Committee Calendar
  • Vaccines and Related Biological Products Advisory Committee – 22 March 2019
  • Electronic Submission of Adverse Event Reports to the Food and Drug Administration Adverse Event Reporting System Using International Council for Harmonisation E2B(R3) Standards – 25 March 2019
Europe
  • Early access to medicines scheme applications: pending, refused, granted (MHRA)
  • Scottish HTA Body OKs Vyxeos & Prevymis, But Rejects Kymriah In Lymphoma (Pink Sheet-$)
India
  • Draft Indian Guide Offers Predictable Regulatory Pathway For Nanopharmaceuticals (Pink Sheet-$)
  • SC asks ex-Ranbaxy promoters to apprise how they'll comply with Rs 3500 cr arbitral award (Economic Times)
General Health & Other Interesting Articles
  • ‘They don’t want his story to end’: Efforts to save the sperm of the deceased come with heartache and tough questions (STAT)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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