Recon: FDA issues refuse-to-file letter for Alkermes depression drug

Posted 02 April 2018 | By Ana Mulero 

Recon: FDA issues refuse-to-file letter for Alkermes depression drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • Alkermes stumbles as FDA refuses to review depression drug (STAT) (Fierce) (CNBC) (BioPharma Dive) (Endpoints) (First Word Pharma)
  • Longtime Novartis exec takes the helm at Macrolide Pharma (Fierce) (Endpoints)
  • Novartis Files Trade Secrets Lawsuit Against Former Executive Who is Now with Biogen (BioSpace)
  • Bouncing back, MediciNova makes big gains after touting triglyceride data from a tiny study (Endpoints) (STAT-$) (Fierce)
  • Drug Price Hike Sparks Senate Probe (WSJ-$)
  • FDA Sends Record-Low Warning Letters To Device-Makers In 2017 As Agency Takes More Personalized Compliance, Enforcement Tack (Medtech Insight-$)
  • Drug companies want Supreme Court to take eye drop dispute (ABC News)
In Focus: International
  • Compugen, AstraZeneca unit in cancer drug development deal (Reuters) (Fierce) (Endpoints)
  • Why GSK Is Exploring The Sale Of Its Indian Consumer Arm (Bloomberg)
  • CFDA Reorganization: Impact for medical device registrants (Emergo)
  • Tata Trusts and Google explore cancer care pact (Economic Times) (Gadgets Now)
  • Guidance on procedures for the analysis of organic products (ANVISA)
  • To boost generic competition, analysis says, FDA should approve drugs OK’d by foreign regulators (STAT-$) (Focus)
  • FDA/IMSN Summit with international drug regulators to discuss medication safety issues (FDA)
  • FDA alerts consumers of a nationwide voluntary recall of topical drug products made by Industria Farmacéutica Andrómaco due to contamination (FDA)
Pharmaceuticals & Biotechnology
  • The drug pricing contract Express Scripts doesn't want you to see (Axios)
  • PhRMA argues early notice of price hikes won't benefit patients (BioPharma Dive)
  • Wholesale drug prices may be rising, but rebates are taking a bigger bite (STAT-$)
  • While Hugin led Celgene, its PAC donated heavily to Menendez (Politico)
  • Abeona taps ex-Alexion CCO as new chief, eyeing commercial operations (Fierce)
  • Half-off sale at Eli Lilly as drug rebating climbs to 51% in 2017 (Fierce)
  • Dendreon chairwoman figures Provenge growth, infrastructure can pave its way into CAR-T (Fierce)
  • Johnson & Johnson, Bayer drop Fox show advertising after host belittles Parkland student (Fierce)
  • TherapeuticsMD Announces Expansion of Board of Directors (Press)
  • BioCryst Pharmaceuticals Files Definitive Proxy Statement in Connection with Pending Merger with Idera Pharmaceuticals (Press)
  • RA Capital Management Opposes BioCryst Pharmaceuticals' Proposed Merger with Idera Pharmaceuticals (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • FDA Acts to Remove the Rx Status of PEG 3500 (Lachman Consultants)
  • The Lab Tests Behind Immuno-Oncology: Precise Enough? (Forbes)
  • In salvage effort, Sellas cherry picks some positive mid-stage cancer vaccine data (Endpoints) (Press)
  • Tired of finishing in last place, Eli Lilly’s new R&D chief wants to shake things up (Endpoints)
  • CRISPR paper that sent stocks tumbling is retracted (STAT)
  • Where marijuana is legal, opioid prescriptions fall, studies find (STAT) (Forbes)
  • The 2-trial hurdle for drug approvals is steadily losing ground. Are we devaluing the industry’s R&D gold standard? (Endpoints-$)
  • Using CRISPR to introduce beneficial but rare gene mutations in sickle cell (Fierce)
  • PharmAbcine Announces FDA Orphan Drug Designation Granted to TTAC-0001 for Glioblastoma Multiforme (Press)
  • Dr. Reddy's Laboratories and its U.S. subsidiary Promius Pharma announce the filing of an NDA for its migraine candidate (Press)
  • Synlogic Doses First Patient in Phase 1b/2a Trial of SYNB1020 for Treatment of Hyperammonemia in Patients with Cirrhosis (Press)
  • Twist Bioscience Completes $50 Million Financing to Fuel Advancement of Digital Storage in DNA and Drug Discovery (Press)
  • Cerus’ RedeS Phase 3 Red Blood Cell Study Expands Into the Continental U.S. (Press)
  • SanBio: Update on Development Progress of Regenerative Cell Medicine SB623 (Press)
  • A CRISPR Way to Restore Hearing (NEJM)
Medical Devices
  • Using Outcomes-Based Pricing For Medical Devices To Improve Cardiovascular Disease Treatment Value (Health Affairs)
  • Takeda’s debts raise doubts over its ability to finance Shire bid (The Telegraph)
  • How Startup Parachute Health Is Bringing E-Commerce To Your Crutches (Forbes)
  • Abiomed wins FDA nod for Impella CP with SmartAssist, taps Trapp as CFO (MassDevice) (Press)
  • Dexcom CEO on ‘treading new ground’ with G6 glucose monitor (Drug Delivery Business News)
  • Why partnerships between medtech companies and doctors are so important (Medical Design & Outsourcing)
  • Motus GI's Pure-Vu system receives US patent for methods for cleaning body cavities (pharmabiz) (Press)
  • Intersect ENT Announces Launch of SINUVA Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps (Press)
  • First Patient Treated on Mevion's Next Generation Proton Therapy System (Press)
  • Beacon Tip Catheters Return to U.S. and Canadian Markets (Press)
US: Assorted & Government
  • New York's Medicaid Drug Cap: A look at the state's new effort to manage pharmaceutical spending (Pew Charitable Trusts)
  • The windfalls of secrecy (Axios)
  • Health Plans Simplify Doctor Credentialing To Boost Medicaid Participation (Forbes)
  • Alphabet's bets on health tech are paying off as portfolio companies go public (CNBC)
  • Does CVS–Aetna Spell the End of Business as Usual? (NEJM)
  • NIH rejected a study of alcohol advertising while pursuing industry funding for other research (STAT)
  • Michigan Governor Snyder Signs Bill Facilitating Patient Access to Interchangeable Biologic Medicine (Michbio)
  • DEA Announces Nationwide ‘Take Back’ Day to Collect Opioids, Unused Medications (E&C)
  • Hospitals Fear Competitive Threat From Potential Walmart-Humana Deal (WSJ)
  • Come for your drugs, leave with more shopping: Walmart's new growth strategy? (Reuters)
  • Shulkin’s Firing Threatens Support for VA Health-Care Overhaul (Bloomberg)
  • Massachusetts, a Health Pioneer, Turns Its Focus to Drug Prices. It’s in for a Fight. (NYT)
  • Is the Trump administration undermining value-based care? (MedCity News)
  • FTC Sending Refund Checks Totaling More Than $355,000 to Consumers Who Bought CogniPrin ‘Memory Improvement’ Supplement (FTC)
  • Patient-Centered Outcomes Research Institute: Review of the Audit of the Financial Statements for Fiscal Year 2017 (GAO)
Upcoming Meetings & Events Europe
  • Even facing Big Pharma together, countries still struggle to haggle (Politico)
  • Supplement 9.4 of the European Pharmacopoeia in force (Swissmedic)
  • All T34 ambulatory syringe pumps – risk of unintended pump shutdown and delay to treatment (MHRA)
  • Mesna 100mg/ml solution for injection/infusion, 5 x 4ml - company led recall (MHRA)
  • HyperMed Imaging, Inc. Announces CE Mark for New HyperView Product (Press)
  • This London startup’s app assists orthopedic surgery patients (MedCity News)
Asia
  • Progress preserved: why industry is balking at Japan’s new pricing reforms (BioCentury)
  • Daiichi Sankyo partners with Crohn’s & Colitis Foundation to draw attention to iron deficiency (Fierce)
  • Drug Risk Information of Ongoing Evaluation (PMDA)
  • [First Announcment] PMDA-ATC GMP Inspection Seminar 2018 (PMDA)
  • Introduction of Connectors that Prevent Misconnection (PMDA)
  • Wize Pharma begins enrollment in phase IV study of LO2A for symptomatic treatment of DES in patients with Sjögren's syndrome (pharmabiz) (Press)
  • Toshiba receives contract to supply heavy-ion therapy system to Yonsei University Health System (phamabiz) (Press)
  • Myriad’s breast cancer diagnostic wins approval in Japan (Drug Delivery Business News) (Press)
  • HIMSS Asia Pacific Soft to launch Innovation Hub (BioSpectrum
India
  • Strides Shasun gets US FDA nod for ibuprofen capsules (pharmabiz) (Business Standard)
  • At the helm at Dr. Reddy's, Erez Israeli will have his task cut out (Economic Times) (The Telegraph) (Business Line)
  • Drug regulator plans national digital database of pharma manufacturers (Economic Times)            
  • NPPA has fixed/revised ceiling prices/retail prices of 869 formulations under Drugs (Prices Control) Order, 2013 in related Notification /order dated 02.04.2018. (NPPA)
  • Mankind to sell 10% stake to ChrysCap in Rs 2.3k-cr deal (Times of India)
  • MedGenome concludes first Indian systematic study on non-invasive prenatal testing (pharmabiz)
  • More children being diagnosed with type 1 diabetes in India (pharmabiz)
  • India's antibiotics usage witnessed maximum rise among LMICs in 15 years: Study (Economic Times)
  • Pharma sector may post single-digit growth in FY18-20: Report (Times of India)
  • CDSCO: FAQ on Grouping Guidelines (CDSCO)
Australia
  • Battle looms over rebates as Labor eyes changes to private health insurance (The Sydney Morning Herald)
  • Labor alleges health insurance ‘cover-up’ (The Australian)
  • Regulators, doctors in firing line after Senate report on pelvic mesh scandal. (The Area News)
Canada
  • Dozens urged to see doctor after needle mistakenly reused at Scarborough health fair (CBC News)
  • Lupin's Pithampur unit gets Health Canada clearance (Economic Times)
  • GUEST COLUMN: Canadian health care — big bills, terrible system (Toronto Sun)
  • COMMENTARY: How AI can prevent suicides in Canada (Global News)
  • Health Canada approves 'Viagra for women’ pill, loosens restrictions on taking it with alcohol (Edmonton Journal)
General Health & Other Interesting Articles
  • Health Care Innovation: Harnessing New Technologies To Benefit Patients (Forbes)
  • Without a single solution, hospitals are taking different paths to interoperability (Fierce)
  • People with sinus infections stay on antibiotics too long (Reuters)
  • UnitedHealth's Optum And Humana In Blockchain Deal To Improve Doctor Directories (Forbes) (CNBC) (Healthcare IT News) (Modern Healthcare) (Fierce)
  • Walmart and Humana: Why Seniors Are at the Center (Fortune)
  • Why Walmart may have designs on Humana, and what it thinks it could get from a deal (CNBC)
  • DNA tests for IQ are coming, but it might not be smart to take one (MIT Technology Review)
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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