Regulatory Focus™ > News Articles > 10 > Recon: EMA Sees 30% Spike in Marketing Applications; Orchard Plans $172M IPO

Recon: EMA Sees 30% Spike in Marketing Applications; Orchard Plans $172M IPO

Posted 05 October 2018 | By Michael Mezher 

Recon: EMA Sees 30% Spike in Marketing Applications; Orchard Plans $172M IPO

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • From mega-round to $172M IPO in weeks, Orchard is bundling cash to back its play on GSK’s gene therapy cast-offs (Endpoints)
  • Fear Of The Flood: Post-IPO Lockup Expiry In Biotech (LifeSciVC)
  • Providers lack confidence in medical device cybersecurity (Modern Healthcare)
  • GW Pharma looks to dispel cannabis stigma with Epidiolex launch (Fierce)
  • Dr Reddy's sells off Tennessee antibiotics facility in restructuring push (BioPharmaDive)
  • Meet the lobbyists behind the new pro-pharma coalition (Politico)
  • A PAC is using the midterms to spotlight high drug prices. Why is it sinking millions into unwinnable races? (STAT)
  • Once again, a New Jersey court gives pharma a boost in lawsuits filed by consumers (STAT)
  • In The Battle To Control Drug Costs, Old Patent Laws Get New Life (KHN)
  • US military project could be seen as a bioweapon, scientists warn (NBC)
In Focus: International
  • Number of new medicine evaluation applications received by EMA up 30% (PharmaLetter-$)
  • EMA Management Board: highlights of October 2018 meeting (EMA)
  • EMA committee recommends restrictions on fluoroquinolone, quinolone antibiotics (Reuters) (EMA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 October 2018 (EMA)
  • MHRA consults on new regulatory framework for ‘no-deal’ scenario (PharmaTimes)
  • China’s Alibaba and in grey area with online drug sales (Financial Times)
  • Expanding on their infectious disease deal, Sanofi turns to Evotec for its drug discovery expertise (Endpoints)
  • European biotech funding on track for record year (Fierce)
  • PRIME status for Orchard’s gene therapy (PharmaTimes)
  • EU accepts marketing application for Paratek’s antibiotic (PharmaTimes)
  • Gilead strikes deal with NHS England on CAR-T Yescarta (PMLive) (Pharmafile)
  • GSK to cut almost 200 jobs at UK site (Pharmafile) (Fierce)
  • Mitsubishi's ALS therapy approved in Canada (PharmaLetter-$)
  • Get a Brexit deal for the sake of public health, ABPI urges negotiators (PharmaLetter-$)
  • Report: Edwards to open 600-job facility in Ireland (MassDevice)
Pharmaceuticals & Biotechnology
  • Cancer policy struggles to keep up with science (Financial Times)
  • How Fast are the FDA Fast Lanes? (PharmExec)
  • Honey, I Shrunk the Biotech Deal (WSJ)
  • Rising Yields Pose Risk to Large-Cap Pharma's Red-Hot Rally (Bloomberg)
  • Should FDA Treat Rare Disease Drugs Differently? (Medpage)
  • Guardant Health soars almost 70% in first day of trading (CNBC)
  • With its rep on the line, Celgene’s newly-filed safety study spurs fresh worries over fate of ozanimod (Endpoints)
  • Xencor’s lead drug fails a PhII test for lupus, shares slide (Endpoints)
  • Arena preparing for trials of first-in-class heart failure drug (Fierce)
  • Lilly, Boehringer hit heart safety mark with Januvia rival Tradjenta. Is that enough? (Fierce)
  • AstraZeneca Tagrisso, Pfizer Xalkori Stand Out Among US FDA’s Single-Arm Oncology Approvals, JAMA Suggests (Pink Sheet-$)
  • Momenta’s biosimilars pullback could portend further industry exits (MedCity)
  • Patient-Reported Outcomes For Organ Transplant Drugs Could Learn From Other Fields (Pink Sheet-$)
  • FDA Warns California Compounder Over Adulterated Drug Products (FDANews-$)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Zydus Cadila gets USFDA nod for breast cancer drug (Economic Times)
  • Valneva Receives FDA Approval for Accelerated Vaccine Dosing Schedule for IXIARO® (Press)
  • Dicerna Announces Late-Breaking Data from the PHYOX Phase 1 Clinical Trial of DCR-PHXC Will Be Presented at ASN Kidney Week 2018 (Press)
  • Audentes Therapeutics to Provide Update on New Positive Interim Data from ASPIRO, the Phase 1/2 Clinical Trial of AT132 in Patients with X-linked Myotubular Myopathy, from the 23rd International Annual Congress of the World Muscle Society (Press)
  • Xencor Announces Topline Results from Phase 2 Study of XmAb®5871 in Systemic Lupus Erythematosus and Selection of Late-Breaking Abstract for Presentation at the 2018 ACR Annual Meeting (Press)
  • Verastem Oncology Announces Publication of the Phase 3 DUO Study Results in the Journal Blood (Press)
  • FluGen Presents First-in-Human Phase 1a Safety and Immunogenicity Data with Novel M2SR Influenza Vaccine at ID Week (Press)
Medical Devices
  • AdvaMed’s CEO dismissed The Bleeding Edge documentary as “entertainment.” He is wrong. (MedCity)
  • Report: MiMedx held lower-cost grafts from federal hospitals (MassDevice)
  • Teleflex picks up Essential Medical and its Manta vascular closure device (MassDevice)
  • Genentech kicks off Phase III trials for eye implant (Drug Delivery)
  • Could bioelectronic medicine help the fight against sepsis? (Medical Design & Outsourcing)
  • Cutera slashes guidance on FDA warning, shares fall (MassDevice)
  • ZEISS Receives FDA Approval for ReLEx SMILE, Expanding Myopia Treatment to Patients with Astigmatism (Press)
  • Final Guidance Issued for Considering Benefit-Risk Factors in 510(k)s with Different Technological Characteristics (FDA Law Blog)
US: Assorted & Government
  • Will This Year’s Lame Duck Conduct “Business as Usual”? (Alliance for a Stronger FDA)
  • Senate Sends Final Opioid Package to President’s Desk (FDANews-$)
  • Akorn Could Alter 'Material Adverse Effect' Law In Delaware (Law360-$)
  • 1st Circ. Won't Rehear Novartis Gleevec Antitrust Suit (Law360-$)
  • Purdue Must Face Trimmed Suit Over Opioid Marketing (Law360-$)
  • Buckman Preemption Fatal to Claim for Violation of the FDCA in IVC Filter Case (Drug & Device Law)
Upcoming Meetings & Events Europe
  • EMA accepts bluebird bio MAA (PharmaLetter-$)
  • GI Dynamics eyes 2019 EU market return for EndoBarrier (MassDevice)
  • Number of new medicine evaluation applications received by EMA up 30% (PharmaLetter-$)
  • Medrobotics touts first EU sale of Flex robotic platform (MassDevice)
  • Class 2 Medicines Recall: Ozurdex 700 micrograms intravitreal implant in applicator manufactured by Allergan Pharmaceuticals Ireland (MDR 95-08/18) (MHRA)
  • Master Key Project Aims To Unlock Japan Rare Cancer Drug Development (Pink Sheet-$)
  • Karnataka drug dept steps up surveillance on banned FDC drug sales (PhamaBiz)
  • Task force for API revival yet to take any steps; China price hikes continue to hit pharma margins (PharmaBiz)
  • China shows interest in buying medicines from India, Pharmexcil proposes visit to Guiyang (PharmaBiz)
  • Extended Biologics Protection In Canada Won’t Take Effect For At Least A Year (BioCentury)
General Health & Other Interesting Articles
  • How Mike Bloomberg's WHO Reappointment Helps Fight Against World's Biggest Killers (Forbes)
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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