Sarepta Therapeutics has announced it has received a Complete Response Letter (CRL) from the FDA  regarding its New Drug Application (NDA) seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy (DMD). The CRL generally cites two concerns: the risk of infections related to intravenous infusion ports and renal toxicity seen in […]

Mylan and Pfizer have announced a definitive agreement to combine Mylan with Upjohn, Pfizer’s off-patent branded and generic established medicines business, creating a new global pharmaceutical company. Under the terms of the agreement, each Mylan share would be converted into one share of the new company. Pfizer shareholders would own 57% of the combined new […]

Watertown-based Lyndra Therapeutics recently announced a partnership with Gilead Sciences to develop and commercialize ultra-long-acting oral HIV therapies. This partnership announcement comes just months after Gilead joined Lyndra’s $60.9 million Series B financing round. Gilead will have exclusive rights to Lyndra’s therapeutics platform for ultra-long-acting formulations related to HIV. Lyndra’s ultra-long-acting dosage form has the […]

“We are excited to have the continued support of high caliber investors who recognize the potential of Kronos’ technology and its team. This financing will help us advance two preclinical programs…, accelerate our research, and further expand the Kronos team in the Boston and San Francisco areas,” said Norbert Bischofberger, Ph.D., President and Chief Executive […]

Woburn-based Frequency Therapeutics has entered into an exclusive license agreement with Tokyo’s Astellas Pharma to develop and commercialize Frequency’s regenerative therapeutic candidate, FX-322, for the treatment of sensorineural hearing loss, the most common type of hearing loss. At present, there are no approved therapeutic options for sensorineural hearing loss. Frequency will receive an upfront payment […]

Bristol-Myers Squibb recently provided an update on the approval process and timeline for its pending merger with Celgene. To allow the transaction to close on a timely basis in light of concerns expressed by the FTC, BMS is planning the divestiture of its anti-inflammatory drug Otezla (apremilast). The divestiture is subject to further review by […]

Karyopharm Therapeutics has announced that the FDA has approved its drug Xpovio (selinexor) in combination with dexamethasone for the treatment of certain adult patients with relapsed or refractory multiple myeloma (RRMM). Approval was granted under the Accelerated Approval Program which was developed by the FDA to allow for expedited approval of drugs that treat serious […]

AbbVie and Allergan announced that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash and stock transaction for a transaction equity value of approximately $63 billion, based on the closing price of AbbVie’s common stock on June 24, 2019. “This is a transformational transaction for both […]

What are the strategic and financial benefits of this transaction? This transaction achieves unique and complementary strategic objectives for both organizations. Combining Allergan’s diversified on-market product portfolio with AbbVie’s growth platform and deep expertise in R&D, commercial strength and international footprint will create a leading biopharmaceutical company with approximately$48 billion in combined 2019 revenue. This […]

GI-focused healthcare company Ironwood Pharmaceuticals has announced that it plans to relocate its headquarters to a new office in downtown Boston from its current location in Cambridge. Ironwood’s new headquarters will occupy approximately 39,000 square feet at 100 Summer Street. The new Boston headquarters is sized to fit the current employee base following completion of […]