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Graham Osborn • 48 Comments
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Tue, Jun. 28, 7:26 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Zavicefta (ceftazidime-avibactam) for the treatment of serious Gram-negative bacterial infections requiring hospitalization. The approval includes intravenous use for adult patients suffering from complicated intra-abdominal infections, complicated urinary tract infections (including pyelonephritis), hospital-acquired pneumonia (including ventilator-associated pneumonia) and treatment of aerobic Gram-negative infections in adult patients who have limited treatment options.
- Zavicefta is a combination antibiotic that contains ceftazidime, a previously approved cephalosporin antibacterial drug and avibactam, a non-beta lactam beta-lactamase inhibitor antibiotic to extend bacterial resistance. The addition of avibactam protects ceftazidime from being broken down by beta-lactamases that are produced by resistant bacteria.
- The product is being co-developed with Allergan (NYSE:AGN), who has commercialization rights in North America (branded as AVYCAZ). AstraZeneca has commercialization rights elsewhere.
Mon, Jun. 27, 7:13 PM
- Australia's Mayne Pharma Group (OTCPK:MAYNF -6.8%) is close to a deal worth about $600M to buy assets from Teva Pharmarceuticals (TEVA -3%), Reuters reports.
- The move is one of a few required of Teva for it to gain FTC approval for a $40B acquisition of Allergan's (NYSE:AGN) generic drugs portfolio. That OK could come as soon as early next month and solidify Teva's position as a generic drugs leader.
- Teva's U.S. asset divestitures would come to about $2B in total, a source said. European divestitures, including a UK/Irish generics business expected to be worth more than $1.3B, should wrap by this fall.
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, 12:30 PM
Thu, Jun. 23, 11:10 AM
- The FDA approves Allergan's (AGN +0.8%) supplemental New Drug Application (sNDA) to update the labeling of combo antibiotic AVYCAZ (ceftazidime and avibactam) to include Phase 3 safety and efficacy data of AVYCAZ, in combination with the antibiotic metronidazole, for the treatment of complicated intra-abdominal infections (cIAI). The undated label also contains data on difficult-to-treat infections due pathogens resistant to ceftazidime and beta-lactam antibiotics.
- The FDA granted accelerated approval of AVYCAZ in February 2015 based on more narrow Phase 2 data.
- It contains ceftazidime, a previously approved cephalosporin antibacterial drug and avibactam, a non-beta lactam beta-lactamase inhibitor antibiotic to extend bacterial resistance. The addition of avibactam protects ceftazidime from being broken down by beta-lactamases that are produced by resistant bacteria. AVYCAZ is a Qualified Infectious Disease Product (QIDP) which adds a five-year period of market exclusivity to the approval.
Tue, Jun. 21, 7:54 AM
- Impax Laboratories (NASDAQ:IPXL) acquires a group of 15 generic drugs from Teva Pharmaceutical Industries (NYSE:TEVA) and affiliates of Allergan (NYSE:AGN) for total consideration of $586M. The transaction also includes the return of the rights to the pending abbreviated New Drug Application (ANDA) for a generic version of Johnson & Johnson's (NYSE:JNJ) Concerta (methylphenidate hydrochloride) to Impax.
- The deal will be immediately accretive to Impax's earnings. The group generated ~$150M in sales and ~$100M in gross profit in 2015. Per IMS, the U.S. market for the portfolio is ~$3.1B.
- Impax will finance the acquisition with cash on hand and $400M in term loans.
- Teva divested the products to satisfy U.S. Federal Trade Commission conditions for its planned acquisition of Allergan's generics business.
Mon, Jun. 13, 3:14 AM
- Looking to bolster its U.S. business, Dr. Reddy's Laboratories (NYSE:RDY) has agreed to buy eight generic medicines from Teva Pharmaceutical (NYSE:TEVA) and Allergan (NYSE:AGN) for $350M in cash.
- The sale to India's second-largest drugmaker could put Teva a step closer to winning U.S. antitrust clearance for its $40.5B acquisition of Allergan's generic drugs portfolio, and is contingent on the deal's approval.
Thu, Jun. 9, 10:47 AM
- Ironwood Pharmaceuticals (IRWD +0.3%) and U.S. commercialization partner Allergan (AGN -0.6%) announce that the FDA has accepted for review their supplemental New Drug Application (sNDA) seeking approval of a 72 mcg dose of LINZESS (linaclotide) for the treatment of chronic idiopathic constipation. The decision date should be early next year.
- LINZESS is currently approved at a dose of 145 mcg.
Wed, Jun. 8, 4:23 PM
- Nano cap Orexigen Therapeutics (NASDAQ:OREX) was up 52% today on a 6x surge in volume in response to its announcement of a favorable Markman ruling related to the company and Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) Contrave patent infringement litigation against Actavis (NYSE:AGN).
- A Markman or claims construction ruling, is a pretrial hearing in which a judge determines the meaning of the disputed patent claims in patent litigation. In this case, Judge Richard Andrews adopted Orexigen's proposed constructions for the majority of the disputed claims, a big win for the company and making it significantly more difficult for Actavis to prevail.
Wed, Jun. 8, 7:46 AM
- Watson Laboratories (NYSE:AGN) filed a motion for voluntary dismissal with the U.S. Court of Appeals yesterday requesting the termination of its appeal of a district court ruling favoring Amarin (NASDAQ:AMRN) related to patent infringement of Vascepa (icosapent ethyl). Amarin sued Watson when it filed an abbreviated New Drug Application (ANDA) seeking approval of a generic version of the product.
- Watson filed the motion following the FDA grant of five-year new chemical entity exclusivity for Vascepa on May 31.
Mon, Jun. 6, 10:04 AM| Mon, Jun. 6, 10:04 AM
Wed, Jun. 1, 8:17 AM
- The FDA approves Allergan's (NYSE:AGN) JUVEDERM VOLBELLA XC, an injectable gel, for lip augmentation and for correction of perioral rhytids (wrinkles around the mouth) in adult patients.
- JUVEDERM VOLBELLA XC was first approved in Europe in 2011 and is currently available in over 70 countries. It will be available to U.S. patients in October.
Tue, May 31, 10:12 AM
Tue, May 31, 8:41 AM
- The FDA approves Allergan's (NYSE:AGN) supplemental New Drug Application (sNDA) seeking approval of TEFLARO (ceftaroline fosamil) for the treatment of pediatric patients aged two months to 18 years who have acute bacterial skin and skin structure infections (ABSSSI), including those caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP).
- According to the company, there are more than 70K hospitalizations in the U.S. each year for kids with ABSSSI.
- TEFLARO, a cephalosporin antibiotic administered intravenously, was first approved in October 2010 for the treatment of adults with CABP and ABSSSI.
Tue, May 24, 7:52 AM
- The FDA accepts for review the New Drug Application (NDA) from Allergan (NYSE:AGN) seeking approval of oxymetazoline HCl cream 1.0% for the treatment of persistent facial erythema (redness) associated with rosacea in adults. The FDA's action date (PDUFA) should be in H1 2017.
- Rosacea is a chronic skin condition affecting more than 16M Americans. It generally affects adults between the ages of 30 and 60 years of age.
Tue, May 24, 7:17 AM
- The Japanese Ministry of Health, Labour and Welfare approves Allergan plc's (NYSE:AGN) BOTOX Vista (botulinum toxin type A product) for the temporary improvement in the appearance of lateral canthal lines (crow's feet lines) in adult patients under the age of 65
- BOTOX, first approved for therapeutic use in the U.S. in 1989, is approved for sale in 94 countries around the world.
Allergan Plc operates as an investment holding company. It is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand, brand generic, over-the-counter and biosimilar products. The company operates through the following segments:... More
Industry: Drug Manufacturers - Other
Country: United States
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