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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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

• Early access to medicines scheme applications: pending, refused, granted (MHRA)
• Scottish HTA Body OKs Vyxeos & Prevymis, But Rejects Kymriah In Lymphoma (Pink Sheet-$)

• 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)

• ‘They don’t want his story to end’: Efforts to save the sperm of the deceased come with heartache and tough questions (STAT)