The biotech amplitude can be an investor's delight, attractive amazing returns, while at the aforementioned time demography them through the affliction of anguish if bets go amiss — all address of make-or-break events.
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RA's Nasty Neutropenia: To stimulate or not to stimulate - ppt ... | epistaxis fever neutropenia after chemotherapy[/caption]
In September, the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) has absent 0.44 percent and the NYSE ARCA BIOTECH INDEX is bottomward 0.63 percent. In comparison, the tech-weighted NASDAQ Composite was bottomward 0.90 percent, but the S&P 500 has rallied 1.01 percent. The achievement of the biotech amplitude has been somewhat in accompany with the broader market, or at atomic technology stocks.
September has been a ages of affluence as far for PDUFA contest are concerned.
The FDA has accustomed 33 NMEs, or new atomic entities, this year in adverse to 22 in the 2016 as a whole.
In September alone, the FDA accustomed two NMEs: Solosec and Aliqopa. On Sept. 12, the FDA accustomed Symbiomix Therapeutics' Solosec to amusement bacterial vaginosis in developed women.
Bayer AG (ADR) (OTCMKTS: BAYRY)'s Aliqopa, a NME, acquired FDA approval Sept. 14 to amusement adults with relapsed follicular lymphoma.
Mylan N.V. (NASDAQ: MYL) faced a setback in September, back the FDA continued the ambition abstracts for its trastuzumab biosimilar until Dec. 3, 2017. The aggregation and its Indian accomplice Biocon said the accommodation will not affect the timeline for commercialization of this artefact in the U.S.
On Sept. 14, Allergan plc Ordinary Shares (NYSE: AGN) and Amgen, Inc. (NASDAQ: AMGN) said the FDA accustomed their ABP 215 for assorted blight indications' the biologic is a biosimilar applicant to bevacizumab, awash beneath the cast name Avastin.
Neos Therapeutics Inc (NASDAQ: NEOS)'s ADHD analysis Adzenys ER, an extended-release amphetamine articulate suspension, was accustomed by the FDA Sept. 15.
GlaxoSmithKline plc (ADR) (NYSE: GSK) and Innoviva Inc (NASDAQ: INVA) appear FDA approval Sept. 18 for their once-daily, distinct inhaler analysis fluticasone furoate/umeclidinium/vilanterol for the analysis of abiding adverse pulmonary diease beneath the cast name Trelegy Ellipta for the analysis of abiding adverse pulmonary disease.
On Sept. 25, the FDA appear approval of Bristol-Myers Squibb Co (NYSE: BMY)'s Opdivo for alleviative hepatocellular blight afterwards above-mentioned sorafenib therapy.
Johnson & Johnson (NYSE: JNJ)'s Janssen Pharma assemblage bootless to defended FDA nod for Sirukumab to amusement rheumatoid arthritis. The accommodation appear Sept. 22 was in band with an August FDA Advising Board advocacy to adios the drug. Source: Y Charts
1. Flexion's Lead Applicant Walks To The FDA Altar
Type of Application: NDA.
Drug/Treatment Candidate: Zilretta - FX006.
Indication: osteoarthritis of the knee.
Date: Oct. 6.
The company, specializing in developing analysis options for musculoskeletal conditions, is animadversion the FDA doors for Zilretta, which employs proprietary microsphere technology accumulation triamcinolone acetonid, a frequently administered, short-acting corticosteroid, with a poly lactic-co-glycolic acerbic matrix. The NDA was accustomed by the FDA in February this year.
2. Mylan Seeks October Rebound With Neulasta Biosimilar
Company name(s): Mylan.
Type of Application: BLA.
Drug/Treatment Candidate: MYL-1401H.
Indication: Reduce the continuance of neutropenia (low calculation of neutrophils) and the accident of agitation associated with neutropenia in developed patients advised with chemotherapy in assertive types of cancer.
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Febrile neutropenia in chidren | epistaxis fever neutropenia after chemotherapy[/caption]
Date: Oct. 9.
Mylan is bound in a acknowledged action with Amgen, the maker of Neulasta, or pegfilgrastim, with the closing claiming that the above has abandoned two of the patents associated with its anti-infection treatment.
3. AcelRx Bracing For Affliction Or Gain?
Type of Application: NDA
Drug/Treatment Candidate: ARX-04 (SAP303), branded as Dsuvia.
Indication: Amusement moderate-to-severe affliction in a medically supervised setting.
Date: Oct. 12.
ARX-04 is a 30 mcg tablets of sufentanil, a awful almighty constructed opioid delivered as generally as already per hour beneath the argot through a disposable, pre-filled, distinct dosage applicator. The aggregation appear in June the FDA notification that an advising board affair is not planned for the NDA.
4. Neurocrine Seeks INGREZZA Approval For Additional Dosing
Type of Application: sNDA.
Drug/Treatment Candidate: INGREZZA 80 mg capsules.
Indication: Amusement adults with tardive dyskinesia.
Date: Oct. 14.
The aggregation accustomed approval for INGREZZA in April this year for an antecedent dosing of 40mg already daily, which could afresh be added afterwards one anniversary to 80mg already daily. The aggregation is now gluttonous approval for addition dosing. Tardive dyskinesia is a action in which one cannot ascendancy anatomy movements.
5. Johnson & Johnson Banks On STELARA sBLA Approval To Ward Off Competition
Type of Application: sBLA.
Drug/Treatment Candidate: STELARA, or ustekinumab.
Indication: Amusement adolescents (12 to 17 years of age) with abstinent to astringent applique psoriasis.
Date: Oct. 15.
STELARA is a animal monoclonal antibiotic that targets interleukin (IL)-12 and IL-23 cytokines. This has already been accustomed for alleviative adults with abstinent to astringent applique crawling back September 2009. An approval is important for the aggregation to accumulate the abundant antagonism at bay. It generated sales of $2.47 billion in 2015, according to Fierce Pharma.
6. Can Antares' Makena sNDA Deliver?
Type of Application: sNDA.
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Febrile neutropenia in chidren | epistaxis fever neutropenia after chemotherapy[/caption]
Drug/Treatment Candidate: Makena Auto Injector.
Indication: Lower the accident of abortive births.
Date: Oct. 17.
Makena is a hydroxy progesterone caporate bang accustomed six canicule a anniversary amid 16 and 20 weeks of abundance to anticipate abortive birth.
7. Antares Seeks A Shot In The Arm With QuickShot
Company name(s): Antares Pharma.
Type of Application: NDA.
Drug/Treatment Candidate: VIBEX QuickShot.
Indication: Amusement developed men with low testosterone associated with a diagnosed action accepted as hypogonadism.
Date: Oct. 20.
VIBEX QuickShot is a drug-device aggregate artefact for the commitment of testosterone enanthate application a subcutaneous auto injector. Hypogonadism is a action in which the anatomy does not aftermath abundant testosterone, the hormone that plays a key role in adult advance and development during puberty, and aliment of musculoskeletal, metabolic and brainy bloom in maturity.
8. Johnson & Johnson's Awaits Twin Approval For RA Drug
Company name(s): Johnson & Johnson's Janssen Biotech.
Type of Application: sBLA.
Drug/Treatment Candidate: Simponi Aria, or Golimumab.
Indication: Amusement adults with alive psoriatic arthritis and adults with alive ankylosing spondylitis.
Date: Oct. 21.
Simponi Aria is a absolutely animal bump afterlife agency (TNF)-alpha inhibitor and has already accustomed for use as an intravenous beverage to amusement adults with moderately to acutely alive RA in aggregate with methotrexate.
8. Alexion Awaits Soliris Sunshine
Type of Application: sBLA.
Drug/Treatment Candidate: Soliris, or Eculizumab.
Indication: Amusement adverse ambiguous Myasthenia Gravis patients who are anti-acetylcholine receptor antibody-positive.
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Febrile neutropenia in chidren | epistaxis fever neutropenia after chemotherapy[/caption]
Date: Oct. 23.
9. Will FDA Go With Panel Advocacy On Shingrix?
Type of Application: BLA.
Drug/Treatment Candidate: Shingrix vaccine, absolute Agenus' adjuvant, QS-21 Stimulon.
Indication: Amusement shingles in adults over 50.
Date: Oct. 24.
Earlier this month, a FDA board voted absolutely that the abstracts presented by the aggregation abutment the ability and assurance of Shingrix for the blockage of canker zoster, or shingles, in adults 50 and older.
10. Can PTC Therapeutics Finally Succeed Afterwards Antecedent Hurdles?
Type of Application: NDA.
Drug/Treatment Candidate: Translarna.
Indication: Duchenne able-bodied dystrophy.
Date: Oct. 24.
Following the antecedent filing, the FDA issued a abnegation to book letter in February 2016. An address was afresh alone in October 2016. The accommodation to resubmit was fabricated in the aboriginal division of 2017, with the FDA Advising Committee's adjudication due after this month.
11. Can Second Time Prove The Charm For TESARO's Rolapitant?
Type of Application: NDA.
Drug/Treatment Candidate: Rolapitant IV.
Indication: For preventing delayed abhorrence and airsickness associated with antecedent and echo courses of emetogenic blight chemotherapy.
Date: Oct. 25.
After accepting a complete acknowledgment letter in January, TESARO has fabricated a resubmission for Rolapitant, an injectable adaptation of its articulate analysis Varubi.
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Febrile neutropenia---paediatrics | epistaxis fever neutropenia after chemotherapy[/caption]
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