Will AstraZeneca Get Bought After All?
Chris DeMuth Jr. • 20 Comments
Chris DeMuth Jr. • 20 Comments
The Preferred Way To Play The Allergan-Pfizer Break Up
Andrew Walker, CFA • 56 Comments
Andrew Walker, CFA • 56 Comments
Wed, Mar. 23, 3:09 AM
- The U.S. Supreme Court today will consider appeals by Christian groups demanding full exemption on religious grounds from a requirement under the Affordable Care Act to provide health insurance covering contraceptives.
- Arguments on seven related cases will focus on whether nonprofit entities can object to a compromise measure offered by the Obama administration, which allowed groups to comply with the law without actually paying for the required coverage, under the 1993 Religious Freedom Restoration Act.
- Related tickers: PFE, MRK, JNJ, TEVA, CHD, OTCPK:BAYRY
Mon, Mar. 14, 4:29 AM
- Shares in the Indian unit of U.S.-based drugmaker Pfizer (NYSE:PFE) fell over 7% today after authorities imposed a ban on its popular cough syrup.
- Corex is a combination of chlopheniramine maleate and codeine syrup - one of 344 drug combinations India barred over the weekend due to the lack of "therapeutic justification."
- The decision is likely to hit Pfizer's revenue and profit. The brand brought in sales of about 1.76B rupees ($26.3M) in the nine months ended December 2015.
Fri, Mar. 11, 2:26 PM
- The FDA has approved the use of Pfizer's (PFE +2.3%) Xalkori to "treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive." The drug is also indicated for "patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test."
- The approval comes after the FDA granted Priority Review to Pfizer's application in December. European regulators are reviewing an application to extend Xalkori's marketing authorization to "include the treatment of adult patients with ROS1-positive advanced NSCLC."
- Four months ago: EC clears expanded label for Pfizer's Xalkori
Wed, Mar. 9, 7:01 AM
Thu, Mar. 3, 8:11 AM
- Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY), Pfizer (NYSE:PFE) and Verastem (NASDAQ:VSTM) ink an agreement to evaluate the combination avelumab and Verastem's lead product candidate VS-6063 in patients with advanced ovarian cancer. A Phase 1/1b study should commence in H2. Financial terms are not disclosed.
- Avelumab, a fully human anti-PD-L1 IgG1 monoclonal antibody, is being co-developed by Merck KGaA and Pfizer for the treatment of a range of cancers. VS-6063 inhibits an enzyme called focal adhesion kinase (FAK) which plays a key role in the development and survival of cancer stem cells. FAK is frequently overexpressed in tumors, enabling cancer cells to evade attack by the immune system.
- Recent research showed that combining FAK inhibitors with immuno-oncology agents may be clinically beneficial.
Thu, Mar. 3, 7:34 AM
- The FDA approves the use of AstraZeneca's (NYSE:AZN) breast cancer med FASLODEX (fulvestrant), in combination with Pfizer's (NYSE:PFE) IBRANCE (palbociclib), for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy.
- The data supporting the approval was generated in the Phase 3 PALOMA-3 study that showed an average increase in progression-free survival (PFS) of 4.9 months in patients receiving FASLODEX/IBRANCE compared to FASLODEX/placebo in women with HR+ HER2- advanced or MBC whose disease had progressed after endocrine therapy. The positive effect on PFS was seen regardless of menopausal status.
- The FDA cleared FASLODEX in 2002 as monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy.
Wed, Feb. 24, 1:40 PM
- ViiV Healthcare, the HIV-focused joint venture between GlaxoSmithKline (GSK -1.1%), Pfizer (PFE -0.5%) and Shionogi Limited (OTC:SGIOF)(OTCPK:SGIOY), announces the results from a 41-week Phase 2a study, ECLAIR, assessing the safety, tolerability, dosing and satisfaction with long-acting, injectable cabotegravir as monotherapy for the prevention of HIV infection in adult males not at high risk of acquiring HIV. The data were presented at the Conference on Retroviruses and Opportunistic Infections in Boston.
- ECLAIR randomized 127 HIV-negative subjects 5:1 to cabotegravir or placebo beginning with a safety assessment on oral cabotegravir 30 mg or placebo tablet for four weeks followed by an intramuscular injection of 800 mg cabotegravir or placebo (sterile saline) every 12 weeks for three cycles.
- The proportions of participants who completed three injections for cabotegravir and placebo were 93% (n=87/94) and 95% (n=20/21), respectively. The incidences of Grade 2 (moderate) to Grade 4 (life-threatening or disabling) adverse events during the injection phase were 80% (n=75/94) and 48% (n=10/21), respectively. The most common Grade 2-4 AE was injection site pain (59% and 5%, respectively). The incidences of all grades of adverse events during the injection phase were 98% (n=92/94) and 90% (n=19/21), respectively.
- Following repeat injections, 74% (n=67/91) favored long-acting cabotegravir over the oral version.
- ViiV intends to advance cabotegravir to Phase 3 development later this year.
- Related tickers: (NASDAQ:GILD)(NYSE:ABT)(NYSE:BMY)(NYSE:JNJ)(NYSE:MRK)(OTCQX:RHHBY)
Wed, Feb. 24, 11:39 AM
- The FDA approves Pfizer's (PFE -0.9%) XELJANZ XR, an extended-release formulation of its JAK inhibitor for the treatment of moderate-to-severe rheumatoid arthritis. The new formulation is an 11 mg tablet taken once per day.
- The recommended dose of original XELJANZ, cleared by the FDA in November 2012, is 5 mg twice daily.
Wed, Feb. 24, 7:11 AM
- Waltham, MA-based Syndax Pharmaceuticals (Pending:SNDX) is set for its IPO of 4.4M shares of common stock at $14 - 16.
- The clinical stage biopharmaceutical firm is developing a small molecule drug called entinostat as a combination therapy for the treatment of a range of cancers. Entinostat inhibits a class of enzymes called histone deacetylases (HDACs), which plays a key role in controlling cell survival, proliferation, angiogenesis and immunity. The company is initially focusing on tumors that show sensitivity to immunotherapy, including lung cancer, melanoma, ovarian cancer and triple negative breast cancer (TNBC).
- Entinostat is currently being evaluated with Merck's (NYSE:MRK) Keytruda (pembrolizumab) in a Phase 1b/2 study in non-small cell lung cancer and melanoma. Another Phase 1b/2 trial should commence in H1 assessing entinostat with Roche's (OTCQX:RHHBY) atezolizumab (MPDL3280A) in TNBC. A third Phase 1b/2 study should commence in H2 evaluating entinostat with Pfizer's (NYSE:PFE) avelumab in ovarian cancer.
- 2015 Financials ($M): Operating Expenses: 21.1 (-1.0%); Net Loss: (24.1) (-21.7%); Cash Burn: (2.4) (+83.3%); Cash: 86.5; Pro Forma Cash: 146.3.
Mon, Feb. 22, 4:01 PM
- A Phase 1/2 clinical trial is underway assessing Capricor Therapeutics' (CAPR) lead product candidate, Orphan Drug-tagged CAP-1002, for the treatment of patients with Duchenne muscular dystrophy-related cardiomyopathy.
- The study, called HOPE-Duchenne, will enroll 24 DMD patients. Those randomized for treatment with CAP-1002 will receive the cells in all three coronary arteries which will enable thorough delivery across the myocardium. The primary endpoint is safety and tolerability. Secondary endpoints include measures of cardiac structure and physical function such as the 6-minute walk test, spirometry and Performance of Upper Limb Scale.
- CAP-1002 is an "off-the-shelf" cell therapy that will be infused via a catheter into the patients' three coronary arteries.
- According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is May 2017. The estimated study completion date is July 2017.
- DMD-related tickers: (NASDAQ:BMRN)(NASDAQ:SRPT)(NYSE:PFE)(NASDAQ:SMMT)(NASDAQ:PTCT)(OTCQB:MRNA)
Mon, Feb. 22, 12:16 PM
- Bristol-Myers Squibb (BMY -0.4%) completes its previously announced sale of its HIV R&D portfolio to ViiV Healthcare, the joint venture of Pfizer (PFE +1.5%) and GlaxoSmithKline (GSK -1.1%).
- Under the terms of the transaction, BMY received an upfront payment of $350M. It can earn up to $518M in development and regulatory milestones and up to $587M for the discovery and preclinical programs plus tiered royalties on commercial sales. ViiV will also pay sales-based milestones of up to $750M for each of the clinical assets and up to $700M for each of the discovery and preclinical programs.
- The deal does not affect BMY's currently marketed HIV drugs.
- Previously: Glaxo to buy HIV assets from Bristol-Myers Squibb (Dec. 18, 2015)
Fri, Feb. 19, 9:29 PM
- The FDA approves Pfizer's (NYSE:PFE) supplement New Drug Application (sNDA) for IBRANCE (palbociclib). It is now cleared for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced/metastatic breast cancer in combination with fulvestrant [AstraZeneca's (NYSE:AZN) FASLODEX] in women with disease progression following endocrine therapy. The review and approval was conducted under the agency's Breakthrough Therapy and Priority Review designations.
- IBRANCE was cleared in February 2015 for the treatment of HR+, HER2- advanced/metastatic breast cancer, in combination with letrozole [Novartis' (NYSE:NVS) Femara], as initial endocrine-based therapy in postmenopausal women.
- Previously: FDA to assess Pfizer's sNDA for expanded use of IBRANCE under Priority Review (Dec. 10, 2015)
- Previously: FDA clears Pfizer breast cancer med (Feb. 3, 2015)
Tue, Feb. 16, 6:57 PM
- George Soros, who has warned of a repeat of the 2008 financial crisis but this time with China as the focus of most problems, exited stakes in several energy-related companies and took a position in Pfizer (NYSE:PFE) during Q4.
- According to a 13-F filing, the Soros fund disclosed it had exited stakes in Chevron (NYSE:CVX), Chesapeake Energy (NYSE:CHK) and NRG Energy (NYSE:NRG), and reduced its position in Dow Chemical (NYSE:DOW); Soros bought ~685K shares in Baker Hughes (NYSE:BHI), which is merging with Halliburton (NYSE:HAL), as well as 50.7K shares in Kinder Morgan (NYSE:KMI).
- Soros also closed his stake in Olin Corp. (NYSE:OLN) and cut his stake in Vista Outdoor (NYSE:VSTO), and took a position valued at $216M in Synchrony Financial (NYSE:SYF), which was spun off from GE.
- Overall, the value of Soros’ holdings fell to $6.05B as of Dec. 31, from $6.61B at the end of Q3.
Tue, Feb. 16, 7:52 AM
- Pfizers' (NYSE:PFE) Wyeth unit reaches agreement in principle to settle a federal case alleging that Wyeth's practices of calculating Medicaid rebates for its GERD drug PROTONIX (pantoprazole sodium) between 2001 and 2006 violated the Federal Civil False Claims Act and other laws.
- The resolve the case, pending in the U.S. District Court for the District of Massachusetts, Wyeth will pay $784.6M, but will not admit liability.
- Pfizer will reissue its Q4 and full-year 2015 financials to include the charge, which will be recorded in "Other income/deductions net." Non-GAAP results will not be affected but, of course, GAAP results will.
Wed, Feb. 10, 7:08 AM
- Based on the recommendation of an independent data monitoring committee, Chugai Pharmaceutical's (OTC:CHGCF)(OTCPK:CHGCY)(OTCQX:RHHBY) Phase 3 clinical trial, J-ALEX, assessing Alecensa (alectinib) compared to crizotinib [Pfizer's (NYSE:PFE) XALKORI] in patients with ALK-positive non-small cell lung cancer (NSCLC) has been stopped early on the basis on meeting its primary endpoint at a pre-planned interim analysis. Results from the Japan-based study showed patients treated with Alecensa lived significantly longer with their cancer worsening (progression-free survival) than those treated with crizotinib.
- J-ALEX was a 207-subject open-label trial in patients ALK fusion protein-positive NSCLC who had not undergone chemotherapy or had one regimen of chemo.
- The results will be presented at a future medical conference.
- The U.S. FDA approved Alecensa in December. It was cleared in Japan in July 2014. Roche licensed it from Chugai in 2012.
Tue, Feb. 9, 10:08 PM
- Earlier today, the FDA's Arthritis Advisory Committee voted 21 - 3 recommending approval of Celltrion's biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab), CT-P13, for all indications.
- If approved, which is probable, Pfizer (NYSE:PFE) will commercialize it in the U.S. under the brand name Inflectra.
- Previously: Ad Comm approaches for Remicade biosimilar (Feb. 5)
Pfizer, Inc. is a research-based, global biopharmaceutical company. The company's global portfolio includes medicines and vaccines, as well as many of the world's best-known consumer healthcare products. It collaborates with healthcare providers, governments and local communities to support and... More
Industry: Drug Manufacturers - Major
Country: United States
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