Recon: NICE Backs Revlimid for First Line Multiple Myeloma Treatment – Regulatory Focus

Posted 17 May 2019 | By Michael Mezher 

Recon: NICE Backs Revlimid for First Line Multiple Myeloma Treatment
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

  • House Passes Legislation Aiming to Shore Up Health Law and Lower Drug Costs (NYTimes) (The Hill) (Politico)
  • Trump administration backs off a proposal to let Medicare plans exclude certain drugs (STAT) (CNBC)
  • Gilead CEO parries with congressional Democrats over an HIV prevention pill (STAT) (Endpoints)
  • AbbVie halts enrollment after brain cancer trial misses goal, shares fall (Reuters) (Endpoints)
  • Genentech forges $800m autoimmune alliance with Parvus (PMLive) (GEN) (Press)
  • Commentary: Novartis CEO says gene therapies promise to upend US health system, pricing structure (CNBC)
  • US FDA labels J&J surgical staplers' recall as severest (Reuters) (MassDevice)
  • Cystic Fibrosis Patients Turn to Experimental Phage Therapy (NYTimes)
  • When science and politics collide: Enhancing the FDA (Science)

In Focus: International

  • UK life science companies show signs of health (Financial Times)
  • After discount row, NICE finally says yes to first line Revlimid (PMLive) (Endpoints)
  • Revlimid, Imnovid combos receive EU approval (PharmaTimes)
  • Celltrion and Samsung duel shaping up as both pledge billions of dollars to biologics (Fierce)
  • GSK and Novartis liniment marketing misled Australian consumers: court (Reuters)
  • EMA imposes formal limit on Xeljanz prescription as regulators continue to review safety concerns (Endpoints) (PharmaLetter-$) (EMA)
  • Withdrawal of marketing authorisations for fenspiride medicines (EMA)

Pharmaceuticals & Biotechnology

  • The NASH dash runs into some early hurdles (BioPharmaDive)
  • FDA's Strengthened Global Inspection Program Helps Ensure Generic Drug Safety (FDA)
  • FDA to Launch Expanded Access Pilot ‘Project Facilitate’ by End of May (Focus)
  • Reassessing Benefit-Risk: FDA Preps for New Guidance (Focus)
  • Amazon’s online drug push has one start-up cutting staff and selling pharmacies to help businesses compete (CNBC)
  • US FDA's New Global Office Aims To Elevate and Enhance Agency’s Role On World Stage (Pink Sheet-$)
  • Pediatric Oncology Advances Could Prompt More FDA-Required Studies (Pink Sheet-$)
  • Where Is J&J Investing For The Future? Cell Therapy, Gene Therapy And RNA (Scrip-$)
  • The More Things Change: Gene Therapy Reopens Orphan Drug ‘Sameness' Debate (Pink Sheet-$)
  • AstraZeneca hires R&D executive to lead breast cancer research, $7B Daiichi drug pact (Fierce)
  • ACRO offers unique insights on risk-based monitoring of clinical trials, calls for adoption of RBM as a best practice (ACRO)
  • Better than CAR-T? Already prepping for a US launch, MorphoSys posts stellar DLBCL data to field against Novartis, Gilead (Endpoints)
  • Focus on specialty drugs reflects ‘cyclical nature’ of biopharma, industry veteran says (MedCity)
  • Ionis peeks behind the science with first official branding—30 years after its founding (Fierce)
  • Takeda, Frazier create Phathom Pharmaceuticals to spur development of GI drug Vonoprazan in $140M play (Endpoints)
  • All in on novel target GSK-3β, Actuate Therapeutics raises $21M+ to bankroll ambitious PhI/II (Endpoints)
  • Following its latest setback, Achillion posts some encouraging PoC data for lead drug (Endpoints)

Pharmaceuticals & Biotechnology: Study Results, Filings & Designations

  • Bristol-Myers Squibb to Present New Data on 20 Types of Cancer from Across its Oncology Portfolio at ASCO and EHA 2019 (Press)
  • U.S. FDA Approves GATTEX® (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS) (Press)
  • CellPoint Plans to Complete Phase 2b Trial in Evaluating the Presence and Severity of Coronary Artery Disease (Press)
  • Therachon to Present Data from Ongoing Phase II Study of Apraglutide for Short Bowel Syndrome (SBS) at Digestive Disease Week (Press)
  • Phase 3 Data of Collagenase Clostridium Histolyticum for the Investigational Treatment of Cellulite to Be Presented at The Aesthetic Meeting 2019 (Press)
  • Novaremed Presents Top-Line Results from Phase 2a Diabetic Neuropathic Pain Study of NRD.E1 at NeuPSIG 2019 (Press)

Medical Devices

  • Q&A: A New Society Targets Digital Medicine Alongside FDA Officials (Focus)
  • Freshly spun-out Alcon posts Q1 sales beat (MassDevice)
  • Abiomed launches Impella CP SmartAssist platform (MassDevice)

US: Assorted & Government

  • Dude, where’s my regulatory framework? As CBD gains popularity, Washington struggles to keep up (STAT)
  • FDA Response To Cannabidiol Confusion Is Slow And Steady (Law360-$)
  • Essure Users Fight To Keep Bayer Injury Suits Alive In Calif. (Law360-$)
  • CAR-T Coverage: CMS Takes Gradual Approach With Eye Toward New Entrants, Indications (Pink Sheet-$)
  • A Chat With Gilead Sciences Legal Ops Leader Gary Tully (Law360-$)
  • Ra Medical files trade libel, settlement breach suit against Strata Skin Sciences (MassDevice)
  • Federal Court Punts Regarding Remedy Related to CMS’ Invalidated Rule Concerning Medicare Hospital Outpatient Payment Rates for 340B Drugs (FDA Law Blog)
  • Novartis Pharmaceuticals Corp. v. West-Ward Pharmaceuticals Int'l (Fed. Cir. 2019) (Patent Docs)
  • Zostavax MDL Judge Dismisses 173 Cases and Scolds Plaintiffs’ Lawyers. (Drug & Device Law)

Upcoming Meetings & Events
Europe

  • Rise in bowel cancer numbers among young adults (PharmaTimes)
  • Yellow Card: please help to reverse the decline in reporting of suspected adverse drug reactions (MHRA)
  • Early access to medicines scheme: expired scientific opinions (MHRA)
  • Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements (MHRA)
  • Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing (MHRA)
  • Magnesium sulfate: risk of skeletal adverse effects in the neonate following prolonged or repeated use in pregnancy (MRHA)

India

  • Pharma companies can’t sell tweaked drugs under old brand name (Economic Times)
  • Maha FDA concludes training on self-audit exercise of over 70,000 drug retailers in state for compliance (PharmaBiz)

Canada

  • Health Canada Explains Revised Fees for Drugs and Devices (Focus)
  • Canadian Policy Paper Demystifies Autologous Cell Therapy Rules (Pink Sheet-$)

Australia

  • Advertising: Complaints and outcomes (TGA)
  • TGA continues action against Peptide Clinics Australia for alleged advertising breaches (TGA)

Other International

  • WHO Stresses Role of GMP in Combatting Antimicrobial Resistance (Focus)
  • Saudi FDA regulatory update: MDR, UDI and Brexit (Emergo)

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.
 
Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Source: https://www.raps.org/news-and-articles/news-articles/2019/5/recon-nice-backs-revlimid-for-first-line-multiple


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