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Regulatory Focus™ > News Articles > 2019 > 7 > Recon: Roche’s Genentech Strikes Deals With Skyhawk, Sosei Heptares and Convelo Therapeutics

Recon: Roche’s Genentech Strikes Deals With Skyhawk, Sosei Heptares and Convelo Therapeutics

Posted 16 July 2019 | By Michael Mezher 

Recon: Roche’s Genentech Strikes Deals With Skyhawk, Sosei Heptares and Convelo Therapeutics

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • How pharma, under attack from all sides, keeps winning in Washington (STAT)
  • 2020 candidates throw punches at drug industry (Politico) (BioPharmaDive)
  • Democrat Harris unveils plan to lower drug costs, put 'people over profit' (Reuters) (The Hill) (Washington Examiner) (Harris)
  • Democratic chair: Medicare negotiating drug prices not moving before August (The Hill)
  • AI Drug Hunters Could Give Big Pharma a Run for Its Money (Bloomberg)
  • Roche's Genentech goes on deal spree, unveiling third deal on the same day (Endpoints)
  • Sosei Heptares pens $1B biobucks GPCR pact with Genentech (Fierce) (Endpoints)
  • Skyhawk Inks Deal With Genentech for Cancer and Neuro Drug Discovery (Xconomy) (Endpoints)
  • J&J warns of hit from generic drugs in third quarter, shares fall (Reuters) (CNBC) (Financial Times)
  • Gilead's Kite builds cell therapy manufacturing quickly even as Yescarta sales grow slowly (Fierce) (Endpoints) (Press)
  • Abbott to hike production of lower-cost glucose monitors as diabetes soars (Reuters)
  • FDA starts speedy review of Novartis’ sickle cell antibody (PMLive) (Endpoints) (Press)
  • Judge reduces Bayer Roundup verdict to $25m from $80m (Financial Times)
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In Focus: International
  • UN wants more urgency in AIDS fight as gains and funding fade (Reuters)
  • First Ebola patient in eastern Congo's main city dies (Reuters)
  • Canada police probing 'possible policy breaches' at National Microbiology Lab (Reuters)
  • Free of Pfizer, AM-Pharma raises €116M for phase 3 (Fierce) (Endpoints) (Press)
  • Drug-related deaths in Scotland rise 27% (Financial Times)
  • GSK took a leap of faith on PARP inhibitors in cancer. It may pay off (STAT)
  • Takeda's translational cell therapy group revs up for a race to the clinic with off-the-shelf CAR-T (Endpoints)
Pharmaceuticals & Biotechnology
  • FDA contributes to hunt for new heart failure endpoints (Fierce)
  • The Bottom of the Stem Cell Barrel (In The Pipeline)
  • Op-Ed: Ask whether a drug works before worrying about what it costs (LA Times)
  • Why Isn’t Insulin a Complex Generic? PA Representative Asks FDA (Focus)
  • H1 analysis: The high-stakes table in the biotech deals casino is paying out some record-setting winnings (Endpoints)
  • What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains (Focus)
  • The opioid drugs scandal is depressingly familiar (Financial Times)
  • Dsuvia: A Dull US FDA Review Preceded The Controversial Approval (Pink Sheet-$)
  • US FDA Compounding Oversight: Not As Bad As FDA Makes It Sound? (Pink Sheet-$)
  • Generic Drug Application Submission Downturn Continued In June (Pink Sheet-$)
  • Part club, part guide, part landlord: Arie Belldegrun is blueprinting a string of bespoke biotech complexes in global boomtowns — starting with Boston (Endpoints)
  • HIV’s genetic code, extracted from a nub of tissue, adds to evidence of virus’ emergence in humans a century ago (STAT)
  • San Diego ophthalmic biotech upstart raises $28M on alternative to corneal transplant (Endpoints)
  • What They Said – FDA Press Releases First Half 2019 – B.G and A.G (Before Gottlieb/After Gottlieb) (Eye on FDA)
  • Enlisting CRISPR in the Quest for an HIV Cure (NIH)
  • Evoke taps new president for North America, continues talent expansion (Fierce)
  • Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses (FDA)
  • Determination That MIOCHOL (Acetylcholine Chloride Intraocular Solution), 20 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Seattle Genetics and Astellas Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer (Press)
  • Athira Pharma Presents Preliminary Results from Phase 1 Trial of NDX-1017 at Alzheimer's Association International Conference 2019 (AAIC) (Press)
  • Cancer Targeted Technology Commences Phase I Clinical Trial in Prostate Cancer Patients with an Innovative Radiotherapy, CTT1403, and Receives a $3.2M NIH Grant to Fund the Trial (Press)
  • Axial Biotherapeutics Announces First Patient Dosed in Phase 1b/2a Clinical Trial of AB-2004 for Treatment of Gastrointestinal Dysfunction and Associated Behavioral Symptoms of Autism Spectrum Disorder (Press)
Medical Devices
  • FDA Looks for New Device Sterilization Methods (Focus)
  • Will Medtech Rise to FDA's Sterilization Challenge? (MDDI)
  • Boston Scientific aims for personalized Parkinson’s therapy with Vercise DBS (MassDevice)
  • Class 1 Device Recall HUDSON RDI NEONATAL ConchaSmart Breathing Circuit (FDA)
  • Novian Health Obtains CE Mark for Novilase Breast Therapy (Press)
US: Assorted & Government
  • Opioid 'kingpin' J&J fueled epidemic, Oklahoma argues at trial's end (Reuters)
  • State drug importation programs will work with the FDA, not outside of it (STAT)
  • Rick Scott: PhRMA hasn't provided 'a single answer' on lower drug prices (The Hill)
  • Following ‘CRISPR babies’ scandal, senators call for international gene editing guidelines (STAT) (Feinstein)
  • Medicare Advantage Overbills Taxpayers By Billions A Year As Feds Struggle To Stop It (KHN)
  • Medicare: Limited Information Exists on the Effects of Synchronizing Medication Refills (GAO)
  • Massachusetts Requires Expert Testimony for Pharmacist Malpractice Claim (Drug & Device)
Upcoming Meetings & Events Europe
  • Exporting active substance manufactured in the UK in a no deal Brexit (MHRA)
  • ‘UK Waiver’ For SPCs Proposed In Case Of No-Deal Brexit (Pink Sheet-$)
  • As of 1 January 2020 the eCTD is mandatory for ALL CEP applications including notifications, revision, renewal and new applications (Council of Europe)
  • EMA Warns of Dosing Errors With Methotrexate Drugs (Focus)
  • MHRA Seeks Input on Patient, Public Engagement (Focus)
  • How an Indian tycoon fought Big Pharma to sell AIDS drugs for $1 a day (Quartz)
  • Cipla forms JV with Jiangsu Acebright for respiratory medicines in China (Economic Times)
  • Experts laud new regulations for clinical trials to make human studies patient-science-centric (PharmaBiz)
  • Maha FDA asks IDMA, IPA and OPPI to upload information related to licenses on SUGAM portal urgently (PharmaBiz)
  • CDSCO to bring in sweeping changes to make regulatory procedures more transparent and speedy: Dr S Manivannan (PharmaBiz)
  • Canada: National Pharmacare Or ‘Fill The Gaps’? (Pink Sheet-$)
  • Views Differ On Australian Proposal To Link Review Of CDx With Drugs (Pink Sheet-$)
General Health & Other Interesting Articles
  • Regulations That Mandate Sepsis Care Appear To Have Worked In New York (NPR)
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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