Regulatory Focus™ > News Articles > Regulatory Recon: Melinta Buys Medicines Co's Infectious Disease Business; Bluebird Buys Facility to

Regulatory Recon: Melinta Buys Medicines Co's Infectious Disease Business Bluebird Buys Facility to Make Viruses for Gene Therapy Delivery (29 November 2017)

Posted 29 November 2017 | By Michael Mezher 

Regulatory Recon: Melinta Buys Medicines Co's Infectious Disease Business Bluebird Buys Facility to Make Viruses for Gene Therapy Delivery (29 November 2017)

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

In Focus: US

  • Alex Azar faces the Senate: What to expect at his hearing today (Politico) (STAT) (Hearing)
  • Warren Asks Trump's HHS Pick About ACA, Drug Prices (Law360-$)
  • Large pharmaceutical companies need to support the growth of startups (STAT)
  • Gene Therapy Hits a Peculiar Roadblock: A Virus Shortage (NYTimes)
  • A Virus Shortage? BlueBird Bio Buys A Factory To Make Its Own (Forbes) (Endpoints)
  • OPDP Issues Third Warning of 2017 (Focus)
  • Gottlieb: More Guidance on Complex Generics Coming (Focus)
  • Pfizer's Prevnar 13 set for price hike in 2018, price-per-dose nears $180 (Fierce) (KHN)
  • Regeneron and Decibel aren't just collaborating: They want to create a whole new partnering model (Endpoints) (Fierce)
  • Pharma's Paradox: Cure A Deadly Childhood Disease And Then Get Attacked On Price (Forbes)
  • Undoing Aging with Molecular and Cellular Damage Repair (MIT Technology Review)
  • Gene Therapy Shows Promise For A Growing List Of Diseases (NPR)
  • How Congress may change the orphan drug tax credit. What you need to know (STAT)
  • University was tipped off to possible unauthorized trials of herpes vaccine (KHN)
  • In latest deal, Melinta executes $270M pact to buy out Medicines Co's infectious disease group (Endpoints) (Fierce)
  • FDA-DoD Turf War Sheds Light On Larger Problem (Forbes)
  • Big Pharma Wins If a Speedy Patent-Challenge Process Dies (Bloomberg)
  • Allergan Hit With Antitrust Suit Over Deal With Tribe (Law360-$)

RAPS Book Release: Fundamentals of EU Regulatory Affairs, Eighth Edition

  • Get the new, updated ultimate reference guide which includes the latest information on the new Medical Device and In Vitro Device Regulations, developments in implementation of the Clinical Trial Regulation and a number of new topics.
  • Learn more and shop now.

In Focus: International

  • FDA, International Regulators Look at Common Challenges, 'Innovation' (FDA Voice)
  • Inside Valeant's Efforts to Be a Normal Drug Company (WSJ)
  • Netherlands health minister threatens compulsory licenses over 'absurd prices' (STAT)
  • WHO: 1 in 10 Medicines in Developing Countries is Substandard or Fake (Focus)
  • The expanding epidemic of HIV-1 in the Russian Federation (PLOS)
  • Dark web drug market growing rapidly in Europe: report (Reuters)
  • Brexit: European Commission proposes legislative amendments for the relocation of the European Medicines Agency and the European Banking Authority from London (EC)
  • EMA Offers Guidance on Post-Brexit Changes as Industry Groups Call for Transition Period (Focus)
  • Pharma industry pleads for Brexit transition period to minimize disruption (PharmaLetter)
  • Bio-investment boasts do not diminish Brexit uncertainties (BioPharmaReporter)
  • EFPIA-PhRMA Principles successfully enable responsible clinical trial data sharing (PhRMA)
  • Asia Regulatory Roundup: CFDA Maps Out Regulatory Transparency (Focus)
  • Mylan Launches Biosimilar Bevacizumab as Abevmy in India (PharmaBiz)
  • NICE changes guidelines on asthma (PharmaTimes)
  • Korea development: Celltrion prepping to enter US generics market (InPharma)
  • Nigeria new attraction for Indian pharma firms (Economic Times)
  • Why A Brazilian State Went From 0 Cases Of Dengue To 35,000 A Year (NPR)
  • WHO fears deadly diphtheria outbreak among Rohingya refugees (Reuters)
  • WHO fears complacency as progress against malaria stalls (Reuters) (LA Times)
  • IGDRP Offers Guidance for Quality Assessors on Drug Substances (Focus)

Pharmaceuticals & Biotechnology

  • The End Of 'Regulatory Science' At US FDA – The Term, Not The Idea (Pink Sheet-$)
  • AZ teams up with G1 on lung cancer combo (PharmaTimes)
  • CDER Conversation: The FDA's Sentinel Initiative (FDA)
  • Doug Williams ups the ante at Codiak Bio to $168.5M in a drive to first human study (Endpoints)
  • Scientist concedes his controversial MS therapy, once a source of great hope, is 'largely ineffective' (STAT)
  • Scientists discover new optimism in fight against Alzheimer's (Financial Times)
  • Advancing Medicinal Nicotine Replacement Therapies as New Drugs – A new step in FDA's comprehensive approach to tobacco and nicotine (FDA Voice)
  • At Long Last, FDA Publishes Draft Guidance on Grandfathering Policy for Products Without a DSCSA Product Identifier. FDA's Message? "Get Packaging" (FDA Law Blog)
  • Payers Like Biosimilars, But Rebates Remain The Bottom Line (For Now) (SCRIP-$)
  • What's Best For A Pharma CEO, An MBA Or A Medical Degree? (SCRIP-$)
  • Unhappy With GDUFA II? Note It For GDUFA III, FDA Says (Pink Sheet-$)
  • UPS digs deeper into drug distribution (BioPharmaDive)
  • New backers Sofinnova and Scopia bring Y-mAb's round to $80M for anti-cancer drugs (Endpoints)
  • Product Focus: Downstream Bioprocessing Trends (Pharmaceutical Manufacturing)
  • Labeling Updates For Old Drugs Could Be Faster Under Streamlining Proposal (Pink Sheet-$)
  • Frazier backs MavuPharma's $20M round, brings in heavyweight execs to lead (Endpoints)
  • RA backs Medeor's $57M round as researchers fast forward to PhIII (Endpoints)
  • Codiak raises $77M to trial exosome-enabled therapies (Fierce)
  • Charles River's capture compound mass spectrometry enables Enyo Pharma's target identification (Fierce)
  • Biotech veterans, chasing Merck and Novartis, tap Frazier, Alpine for cash to move STING modulators into the clinic (Fierce)
  • Scangos recruits Washington University prof Virgin for Vir CSO role (Fierce)
  • FDA Warning Wire: Issues At Pharmacy Linked To Vision Loss (Law360-$)
  • Almac looking to move into sterile injectables in the long-term (InPharma)
  • WCG acquires pharmacovigilance firm Vigilare (OutsourcingPharma)
  • Prospective Grant of an Exclusive Patent License: Concatenated L2 Peptide Based Human Papillomavirus Vaccines (NIH)
  • Prospective Grant of Exclusive Patent Commercialization License: N6, A Novel, Broad, Highly Potent HIV-Specific Antibody (NIH)
  • Prospective Grant of Exclusive Patent License: T-Cells Transduced with HLA A11 Restricted CT-RCC HERV-E Reactive T-Cell Receptors for the Treatment of Renal Cell Carcinoma (NIH)
  • Roxane Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for ROXICODONE (Oxycodone Hydrochloride) Sustained-Release Tablets, 10 Milligrams and 30 Milligrams (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Amphivena Receives Orphan Drug Designation for AMV564, a Novel CD33/CD3 T-Cell Engagement Therapy for the Treatment of Acute Myeloid Leukemia (Press)
  • Ipsen announces publication in Neurology of results of two studies demonstrating the efficacy and safety of Dysport® (abobotulinumtoxinA) in adult patients with lower limb spasticity (Press)
  • Astellas to Present New Data Exploring Gilteritinib in Newly Diagnosed Acute Myeloid Leukemia (AML) Patients at the 2017 ASH (Press)
  • FDA accepts Kyowa Hakko Kirin's BLA for lymphoma candidate (PharmaLetter-$)

Medical Devices

  • FDA Issues Two Guidances on CLIA Waiver Applications, 510(k) Dual Submissions (Focus)
  • X-rays and Children: FDA Issues Guidance to Minimize Dose (FDA)
  • Did TransEnterix Grease Palms to Sell a Robot? (MDDI)
  • Medical Devices; Exemption from Premarket Notification: Class II Devices; Surgical Apparel (FDA)
  • Philips, Children's Hospital & Medical Center launch 10-year partnership (MedCityNews)
  • Eisai tracking device keeps tabs on out-and-about dementia patients (Fierce)
  • Boston Scientific takes a $3B hit on latest Lotus valve delay (MassDevice)
  • Boston Scientific has trouble delivering its valve (EP Vantage)
  • Ethicon Endo-Surgery Generator G11 Vulnerability (ICS-CERT)
  • Medtronic retools SynchroMed II infusion pump (MassDevice)
  • GE Healthcare launches Drawbridge Health blood collection biz (MassDevice)
  • Insightec wins FDA nod for Exablate Neuro glioblastoma trial (MassDevice)
  • Pavmed files FDA 510(k) for CarpX carpal tunnel device (MassDevice)
  • BD tacks another extension onto Bard tender offer (MassDevice)
  • Stimwave Granted New FDA 510(k) Clearance for the SandShark Injectable Anchoring System, Fixating Stimulators without Surgery (Press)

US: Assorted & Government

  • Securities class action lawsuit served on Dr Reddy's in US (Economic Times)
  • US House panel convenes in Baltimore to assess opioid epidemic (Baltimore Sun)
  • Jim Renacci says suing drug manufacturers over opioid epidemic isn't part of the solution (Cleveland)
  • Former DEA officials call for repeal of law that weakened enforcement (Washington Post)
  • NIH Seeks Additional Comments on Genomic Data Sharing Policy (GenomeWeb)
  • Stryker Unit Settles Biomet Trade Secret Suit (Law360-$)
  • PMA Preemption & Fraud by Omission/Concealment (Drug & Device Law)
  • Alkermes hit with 3 gender discrimination lawsuits from former staffers (Fierce)
  • Patent Day At The Supreme Court: A Split Decision On Split Decisions? (Pink Sheet-$)

Upcoming Meetings & Events

Europe

  • Partnerships in Clinical Trials 2017: Live updates from Amsterdam (OutsourcingPharma)
  • Butterfly Medical wins CE Mark for in-office benign prostate hyperplasia device (MassDevice)

Asia

  • Insightec: The Taiwanese Food and Drug Administration (TFDA) Approved Exablate Neuro for the Treatment of Essential Tremor (Press)

India

  • India has a long way to go in cancer insurance even as disease increases annually: Sanjay Tiwari (PharmaBiz)

Australia

  • Australian State Passes Assisted Dying Law (NYTimes)

General Health & Other Interesting Articles

  • About 15% of Americans with HIV don't know they're infected, CDC report says (LA Times)
  • One in three US adults with hearing problems don't seek help (Reuters)
  • NIAID scientists link cases of unexplained anaphylaxis to red meat allergy (NIH)

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? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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