Fri, Jun. 24, 10:25 AM
- Intrepid biotech investors are, no doubt, seriously considering deploying some cash today in response to the (hopefully temporary) bearish reaction to the Brexit vote. Nasdaq is currently down 2.7%, the Dow 2.2% and the IBB 3.3%.
- Representative tickers: (GILD -2.2%)(GSK -2.4%)(AZN -2.7%)(PFE -1.1%)(MRK -1.9%)(CELG -3.2%)(BMY -2%)(BIIB -2.4%)(AMGN -2.7%)(AGN -2.8%)(TEVA -0.8%)(ABT -3.4%)(MDT -1.4%)
Thu, Jun. 23, 9:41 AM
Mon, Jun. 20, 7:46 AM
- GlaxoSmithKline's (NYSE:GSK) investigational once-daily closed triple combination therapy was superior to AstraZeneca's (NYSE:AZN) twice-daily Symbicort Turbohaler (budesonide/formoterol 400/12 mcg) in a Phase 3 study, FULFIL, in patients with chronic obstructive pulmonary disease (COPD).
- The double-blind, double-dummy, parallel group study randomized 1,810 subjects to receive either Glaxo's fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or budesonide/formoterol. The co-primary endpoints were a measure of lung function called trough FEV1 (forced expiratory volume in one second) and quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ) at week 24. Patients in the FF/UMEC/VI cohort experienced a statistically significantly greater increase in FEV1 while half achieved the minimum clinically important difference in SGRQ of -4 units (compared to 41% for budesonide/formoterol).
- At week 24, the incidence of investigator-reported serious adverse events for FF/UMEC/VI and budesonide/formoterol were 5.4% and 5.7%, respectively, including worsening of COPD (1.3%, 2.3%), pneumonia (1.0%, 0.3%) and cardiac disorders (0.3%, 1.0%).
- Full results from FULFIL will be presented at a future scientific conference.
- Regulatory applications in the U.S. and Europe are on tap for Q4.
Wed, Jun. 15, 4:19 PM
- In a regulatory filing, Relypsa (NASDAQ:RLYP) reports that retail prescriptions for hyperkalemia drug Veltassa (patiromer) in May were 1,230, up 32.5% from April. New patients who started with a free starter supply totaled 1,385 (+13.9%). Units sold in the hospital/institution setting, however, were down 3.8% (277 in May versus 288 in April).
- The company says the numbers are estimates as they have not been verified by a third party.
- Investors are looking for a healthy ramp considering the company's window of opportunity since competitor AstraZeneca (NYSE:AZN) received a Complete Response Letter (CRL) from the FDA last month regarding its NDA for ZS-9.
- Previously: FDA rejects AstraZeneca's ZS-9 NDA; competitor Relypsa up 29% premarket (May 27)
- Update: Shares are now up 6% on turnover of ~100K.
Wed, Jun. 15, 12:45 PM
Thu, Jun. 9, 7:35 AM
- Aspen Global acquires the ex-U.S. rights to AstraZeneca's (NYSE:AZN) seven-product anesthesia portfolio. Under the terms of the deal, AstraZeneca will receive an upfront payment of $520M, sales-based milestones up to $250M and double-digit royalties on net sales.
- The portfolio consists of five local anesthetics: Carbocaine (mepivacaine), Citanest (prilocaine), Marcaine (bupivacaine), Naropin (ropivacaine) and Xylocaine (lidocaine/lignocaine), one topical anesthetic: EMLA (lidocaine + prilocaine) and one short-acting IV anesthetic/sedative: Diprivan (propofol).
Fri, Jun. 3, 7:37 AM
- Bayer (OTCPK:BAYRY) and Espoo, Finland-based Orion expand their 2014 agreement to jointly develop BAY-1841788 (ODM-201) in prostate cancer, currently in Phase 3 development (ARAMIS study) for the treatment of high-risk non-metastatic castration-resistant prostate cancer.
- The new indication will be for the treatment of newly diagnosed metastatic hormone-sensitive prostate cancer, in combination with docetaxel, in men who are starting first-line hormone therapy.
- A Phase 3 study, called ARASENS, will begin enrolling patients in late Q4. The double-blind, placebo-controlled trial will randomize ~1,300 subjects 1:1 to receive either BAY-1841788 (ODM-201) or placebo in combination with an androgen deprivation therapy of the investigator's choice started no more than 12 weeks before randomization. The primary endpoint is overall survival.
- BAY-1841788 is an oral androgen receptor antagonist.
- Prostate cancer-related tickers: (NASDAQ:MDVN)(OTCPK:ALPMY)(NYSE:VRX)(NASDAQ:TTHI)(NASDAQ:EDAP)(NASDAQ:TKAI)(NYSE:JNJ)(NASDAQ:TSRO)(NYSE:AZN)(NASDAQ:EGRX)(NASDAQ:OGXI)
Thu, Jun. 2, 8:21 AM
- Buoyed by discussions with the FDA, GlaxoSmithKline (NYSE:GSK) plans to file its New Drug Application (NDA) seeking approval of its triple combination therapy for the treatment of chronic obstructive pulmonary disease (COPD) by the end of 2016 instead of H1 2018, as previously expected.
- The company's candidate, a combination of fluticasone furoate, umeclidinium and vilanterol (FF/UMEC/VI), employs three different mechanisms of action to help open the airways of COPD patients, a more effective approach compared to current doublet therapies.
- Glaxo aims to maintain its lead in respiratory medicine, especially against AstraZeneca (NYSE:AZN) and Novartis (NYSE:NVS) who are developing their own "closed triple" combination products.
Thu, Jun. 2, 7:21 AM
- Privately held Grunenthal GmbH inks a license deal with AstraZeneca (NYSE:AZN) for the rights to gout medicine Zurampic (lesinurad) in Europe and Latin America. The Aachen, Germany-based firm will have exclusive rights to Zurampic in all European Union member states, Switzerland, Iceland, Norway and Lichtenstein and all Latin American countries including Mexico, the Dominican Republic and Cuba. It also has the exclusive rights to the fixed-dose combination of lesinurad and allopurinol, currently in clinical development, in these markets.
- Under the terms of the agreement, AstraZeneca will receive up to $230M in sales and other milestones over the lifetime of the contract in addition to low double-digit royalties. AstraZeneca will initially manufacture and supply Zurampic to Grunenthal and will handle the European post-approval commitment on its behalf. Beginning October 1, 2021, Grunenthal will have the option to take over manufacturing.
- AstraZeneca says the deal will not impact its previously announced guidance for 2016.
Fri, May 27, 10:08 AM
- Results from a Phase 3 clinical trial, FALCON, showed AstraZeneca's (AZN -0.4%) FASLODEX (fulvestrant) was superior to Arimidex (anastrozole) in extending progression-free survival (PFS) in postmenopausal women with hormone receptor-positive (HR+) breast cancer who had not had prior hormonal treatment. Full results will be presented at an upcoming medical conference (probably ASCO).
- FASLODEX is currently approved for the treatment of HR+ HER2- breast cancer, in combination with palbociclib in patients previously treated with endocrine therapy and in HR+ breast cancer in patients previously treated with antiestrogen therapy.
Fri, May 27, 9:46 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of AstraZeneca's (AZN -0.7%) fixed-dose combination of saxagliptin and dapagliflozin for the treatment of adults with type 2 diabetes (T2D).
- Clinical data supporting the application showed the saxa/dapa combo with metformin statistically significantly reduced HbA1c levels compared to patients treated with placebo that required additional control to existing saxagliptin and metformin or dapagliflozin and metformin therapy. Another study showed the saxa/dapa combo added to metformin produced superior reductions in HbA1c compared to dapagliflozin or saxagliptin alone added to metformin.
- A final decision from the European Commission usually takes ~60 days.
- In October 2015, the FDA rejected the company's NDA citing the need for more clinical data.
- Related tickers: (NYSE:NVO)(NYSE:JNJ)(NYSE:SNY)
Fri, May 27, 7:25 AM
- In a shot to the corporate solar plexus, AstraZeneca (NYSE:AZN) receives a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking approval of hyperkalemia drug ZS-9 (sodium zirconium cyclosilicate). In a statement, it said the CRL refers to observations from a pre-approval on-site manufacturing inspection. The agency also cited the receipt of recently-submitted data which it has yet to review. The company is reviewing the CRL to determine appropriate action.
- AstraZeneca acquired the rights to ZS-9 via its $2.7B acquisition of ZS Pharma in December 2015.
- Competitor Relypsa (NASDAQ:RLYP) is up 29% premarket on robust volume. Its hyperkalemia drug, Veltassa (patiromer) was approved by the FDA in October 2015.
- AstraZeneca is down 1% premarket on increased volume.
Thu, May 26, 11:52 AM
- Nano cap Biodel (BIOD -14.3%) gives all its merger news pop back as shares have completely retraced from yesterday's up move which was over 40% at one time but failed to hold.
- Tuesday evening, the company announced that it would combine with privately held Albireo. The new company will do business as Albireo Pharma and trade under the symbol "ALBO." A syndicate of institutional investors, including AstraZeneca (AZN -0.1%) will invest $10M in the new organization.
- Under the terms of the deal, Biodel shareholders will own ~33% of the combined firm while Albireo shareholders will own ~67%. Albireo chief Ron Cooper will be serve as President & CEO of Albireo Pharma while Chairman David Chiswell, Ph.D,, will continue as Chairman. The transaction should close in Q3.
- The combined firm will focus on developing bile acid modulators for the treatment of a range of liver, gastrointestinal and other disorders. Albireo's lead product candidate is Phase 2-stage A4250 for the treatment of a pediatric orphan disease called Progressive Familial Intrahepatic Cholestasis, an inherited disorder characterized by the buildup of bile in the liver which usually leads to liver failure.
Wed, May 25, 9:00 AM
- According to Bloomberg, Celgene (NASDAQ:CELG) is considering a bid for Medivation (NASDAQ:MDVN), currently trying to hold off Sanofi (NYSE:SNY). Other suitors supposedly in the mix are Pfizer (NYSE:PFE), AstraZeneca (NYSE:AZN) and Amgen (NASDAQ:AMGN).
- Sanofi is trying to replace Medivation's board after it rejected its per-share offer of $52.50.
- Previously: Amgen another possible Medivation suitor (May 5)
Mon, May 23, 11:04 AM
- The FDA has a busy docket this week with two Ad Comm meetings and four product approval decisions.
- On Tuesday, the Circulatory System Devices Panel of the Medical Devices Advisory Committee will discuss the Premarket Approval Application (PMA) from St. Jude Medical (STJ -0.2%) seeking approval of its AMPLATZER Patent Foramen Ovale (PFO) Occluder, a permanent cardiac implant for PFO closure indicated for preventing recurrent ischemic stroke in patients who have had a cryptogenic (uncertain origin) stroke due an embolism presumed to have originated through an opening in the heart.
- On Wednesday, the Endocrinologic and Metabolic Drugs Advisory Committee will review the NDAs for Sanofi's (SNY -1.3%) fixed ratio combination of insulin glargine and lixisenatide for the treatment of adults with type 2 diabetes.
- No later than Thursday, the FDA will decide on Sarepta Therapeutics' (SRPT +2.3%) New Drug Application (NDA) seeking approval of eteplirsen for children with Duchenne muscular dystrophy amenable to skipping exon 51. Also, no later than Thursday, it will decide on AstraZeneca's (AZN -0.3%) NDA seeking approval of ZS-9 for hyperkalemia.
- No later than Friday, the agency will decide on Titan Pharmaceuticals' (TTNP +8.8%) NDA seeking approval of its Probuphine subdermal implant for the maintenance treatment of opioid addiction. Also, no later than Friday, it will decide on Vanda Pharmaceuticals' (VNDA +0.3%) supplemental NDA seeking approval of Fanapt for the maintenance (long term) treatment of schizophrenia in adults.
Wed, May 18, 7:21 AM
- A Phase 3 clinical trial, called GOLD, assessing the combination of AstraZeneca's (NYSE:AZN) Lynparza (olaparib) and the chemo agent paclitaxel in patients with advanced gastric cancer failed to achieve its primary endpoint of a statistically valid increase in overall survival (OS) compared to paclitaxel alone.
- GOLD, conducted in China, Japan, South Korea and Taiwan, was a randomized, double-blinded, placebo-controlled study in 525 Asian patients with advanced HER2-negative gastric cancer (including the gastro-esophageal junction) who had progressed following first-line therapy. The incidence of gastric cancer in East Asia is 9x higher than the G6 countries.
- Full results will be presented at a upcoming medical conference.
- Lynparza is approved in over 40 countries for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in partial or complete response to platinum-based chemo. In the U.S. it is approved for patients with deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemo.
AstraZeneca Plc is a global research-based biopharmaceutical company, which primarily focuses on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. The... More
Industry: Drug Manufacturers - Major
Country: United Kingdom
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