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

• 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)

• Number of new medicine evaluation applications received by EMA up 30% (PharmaLetter-$)
• EMA Management Board: highlights of October 2018 meeting (EMA)
• EMA committee recommends restrictions on fluoroquinolone, quinolone antibiotics (Reuters) (EMA)
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 October 2018 (EMA)
• MHRA consults on new regulatory framework for ‘no-deal’ scenario (PharmaTimes)
• China’s Alibaba and JD.com in grey area with online drug sales (Financial Times)
• Expanding on their infectious disease deal, Sanofi turns to Evotec for its drug discovery expertise (Endpoints)
• European biotech funding on track for record year (Fierce)
• PRIME status for Orchard’s gene therapy (PharmaTimes)
• EU accepts marketing application for Paratek’s antibiotic (PharmaTimes)
• Gilead strikes deal with NHS England on CAR-T Yescarta (PMLive) (Pharmafile)
• GSK to cut almost 200 jobs at UK site (Pharmafile) (Fierce)
• Mitsubishi's ALS therapy approved in Canada (PharmaLetter-$)
• Get a Brexit deal for the sake of public health, ABPI urges negotiators (PharmaLetter-$)
• Report: Edwards to open 600-job facility in Ireland (MassDevice)

• 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-$)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar
• Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee – 14 November 2018
• Anesthetic and Analgesic Drug Products Advisory Committee – 15 November 2018

• 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)

• How Mike Bloomberg's WHO Reappointment Helps Fight Against World's Biggest Killers (Forbes)