October was a airy ages for the markets, and biotech stocks were no exception. The iShares NASDAQ Biotechnology Index (NASDAQ: IBB) had slipped about 17 percent in the period. This compares to S&P 500’s 7 percent retreat.
As we access the aftermost leg of the year, actuality are a few PDUFA catalysts in November that could admonition actuate as to area biotech stocks are headed.
PDUFA dates are deadlines for the FDA to analysis new drugs. The FDA is commonly accustomed 10 months to analysis new drugs. If a biologic is called for antecedence review, the FDA is allotted six months to analysis the drug. These time frames activate on the date that an NDA is accustomed by the FDA as complete.
FDA’s Anesthetic and Analgesic Biologic Products Advisory Committee, which met Oct. 11 to altercate the NDA, disqualified adjoin acknowledging the biologic by an 8-7 margin. Trevena’s shares accept plummeted about 70 percent back Oct. 8 in acknowledgment the absolution of the FDA Committee’s conference document.
The Anesthetic and Analgesic Biologic Products Advisory Committee, which met Oct. 12, voted 10-3 in favor of advising the approval of the activity candidate.
Egrifta was initially accustomed by the FDA in Nov. 2010 to abate abdomen adipose tissue – abysmal abdomen fat surrounding the liver, abdomen and added abdomen organs – in HIV patients, who accept accomplished lipodystrophy as a ancillary aftereffect of antiretroviral therapy.
The aggregation is now gluttonous an amplification in characterization to accommodate a single-vial conception based on bioequivalence studies. The single-vial conception is four times added concentrated than the currently commercialized formulation.
Following the affair of a complete acknowledgment letter in June 2017, Coherus fabricated a resubmission, with the resubmitted appliance accustomed for analysis in May.
Neulasta is Amgen, Inc. (NASDAQ: AMGN)’s white-cell advocacy ameliorative acclimated to abatement the accident of neutropenia (abnormally low neutrophil count), which can advance to patients appliance potentially activity aggressive infections afterward chemotherapy.
Merck is gluttonous FDA approval for Keytruda for a new indication, namely hepatocellular blight – a anatomy of alarmist cancer. The appliance is based on the Phase 2 KEYNOTE-224 study.
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The BLA filed by Novartis’ Sandoz all-encompassing assemblage was accustomed Jan. 16, 2018. Accustomed the 10-month accepted analysis period, the PDUFA date is estimated to be Nov. 16. The rights to Humira, the aboriginal Adalimumab, are now endemic by AbbVie Inc (NYSE: ABBV).
An Adcom affair for the applicant is appointed for Nov. 14.
The NDA was accepted antecedence analysis status. This biologic has a different apparatus of advancing the tumor’s genetics, rather than its armpit of agent in the body.
Following the aboriginal filing, the FDA issued a refuse-to-file letter in February 2016. Catalyst resubmitted the application, which was after accustomed antecedence analysis status. The PDUFA date is set for Nov. 28.
Firdapse, according to the company, is the aboriginal and alone accustomed biologic in Europe for appropriate analysis in adults with LEMS, a attenuate autoimmune disorder.
Lorlatinib is an anaplastic lymphoma kinase, or ALK, tyrosine kinase inhibitor, or TKI for the analysis of patients with ALK-positive metastatic NSCLC ahead advised with one or added ALK TKIs.
Following FDA’s accommodation to extend the analysis aeon by three months, the antecedent PDUFA date of August was pushed astern to October.
A collective board of Psychopharmacologic Drugs Advisory Board and Biologic Assurance and Risk Administration Advisory Board will altercate Nov. 1 efficacy, assurance and risk-benefit contour of Alkermes Plc (NASDAQ: ALKS)’s NDA for buprenorphine and samidorphan sublingual tablets, actuality evaluated as an accessory analysis of above depressive disorder.
The aforementioned collective board will altercate Nov. 2 the efficacy, safety, and benefit-risk contour of SAGE Therapeutics Inc (NASDAQ: SAGE)’s brexanolone 5 mg/mL intravenous injection, activated for postpartum depression.
Mallinckrodt’s all-encompassing SpecGx Inc’s NDA for an immediate-release articulate book conception of oxycodone – MNK-812 – will be discussed by the aforementioned collective board Nov. 14. This activity asset is advised to administer affliction astringent abundant to crave an opioid analgesic and for which another treatments are inadequate.
The collective board will additionally actuate whether the sponsor aggregation accustomed that the abuse-deterrent backdrop of the proposed artefact are acceptable to accommodate this admonition in the artefact label, and whether the artefact should be approved.
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