Pharmaceutical Business News

FDA approves new treatment for rare hereditary disease

The U.S. Food and Drug Administration recently approved Takhzyro (lanadelumab), the first monoclonal antibody approved in the U.S. to treat patients 12 years and older with types I and II hereditary angioedema (HAE). HAE is a rare and serious genetic disease that affects people with low levels of and poorly functioning C1-INH proteins in the body. This results in recurrent, unpredictable episodes of severe swelling in different areas of the
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Cannabidiol-based Therapy Effective in Irritable Bowel Disease and Colitis: Early Study

FSD Pharma Inc. reports today that its strategic R&D partner, SciCann Therapeutics Inc. (“SciCann”), has achieved positive results in a pre-clinical efficacy study of its proprietary “Steady Stomach” CBD combination product for Inflammatory Bowel Disease (IBD). Under the terms of the agreement between FSD and SciCann, FSD Pharma holds exclusive marketing and distribution rights for the “Steady Stomach” product in Canada. The “Steady Stomach” product is a patent-pending combination of
Pharmaceutical Business News

Biogen, Eisai’s Alzheimer’s drug succeeds in mid-stage trial, shares soar

(REUTERS)  Japanese drugmaker Eisai Co and Biogen Inc said that the final analysis of a mid-stage trial of their Alzheimer’s drug showed positive results for patients who received the highest dose. The news sent Eisai’s shares up as much as 14.6 percent in Friday morning trading in Tokyo while Biogen’s shares were up 7 percent at $320 in after-hours trading. The companies said in a July 5 statement the highest
Pharmaceutical Business News

Set Back for Pancreatic Cancer: CARRIE study did not meet primary or secondary endpoints

Merrimack Pharmaceuticals, Inc., a clinical-stage oncology company focused on biomarker-defined cancers, today announced top-line results from the CARRIE study, a randomized Phase 2 trial evaluating the addition of MM-141 (istiratumab) to standard-of-care treatment in patients with previously untreated metastatic pancreatic cancer and high serum levels of free Insulin-like Growth Factor-1 (IGF-1). The study did not meet its primary or secondary efficacy endpoints in patients who received MM-141 in combination with
Pharmaceutical Business News

Shire bid marks Takeda’s latest – and biggest – push for global status

(Reuters) Takeda Pharmaceutical Co Ltd’s $64 billion bid for London-listed rare disease specialist Shire Plc bolsters its credentials as Japan’s most outward facing drugs firm, a mold-breaking image that has been more than a decade in the making. Under chief executive Christophe Weber and his predecessor, Yasuchika Hasegawa, Takeda has cut its exposure to Japan, brought in expertise through overseas acquisitions and thrown open its leadership ranks to foreign talent.
Pharmaceutical Business News

Merck’s Keytruda helps lung cancer patients live longer in trial

Merck & Co's blockbuster drug Keytruda helped previously untreated lung cancer patients live longer in a late-stage trial, potentially cementing its position as the dominant player in the lucrative lung cancer market. Merck is already considered the frontrunner in the space and Keytruda is expected to earn peak sales of over $10 billion in 2023, according to Credit Suisse. Keytruda is already approved in the U.S. to treat patients with
Pharmaceutical Business News

Celgene Partners with Prothena Therapeutics in Potential $2B Deal

(BioSpace) Shares of Prothena Corporation plc have shot up more than 18 percent in premarket trading this morning after the company forged a collaboration with pharma giant Celgene to develop new therapies for a broad range of neurodegenerative diseases, including Alzheimer’s and ALS. Celgene will pay Prothena $150 million in upfront money with the promise of future regulatory and commercial milestone payments. According to a filing with the U.S. Securities
Pharmaceutical Business News

FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing

The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). “This is the first treatment approved for stage III unresectable non-small cell lung cancer to reduce the risk of the cancer progressing, when the
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Merck KGaA and Pfizer’s Avelumab fails in trial

(Marketwatch) Merck KGaA and Pfizer Inc. said on Thursday that avelumab, a cancer immunotherapy, failed to meet the primary objective of a phase 3 trial in patients with a type of lung cancer. The trial didn't meet the endpoint of improving overall survival in patients whose tumors are PD-L1 positive, the companies said. The Javelin Lung 200 trial compared avelumab to docetaxel, a chemotherapy drug, in patients with advanced non-small-cell
Gene Therapy Pharmaceutical Business News

Abeona Receives FDA Regenerative Medicine Advanced Therapy Designation for Gene Therapy in Epidermolysis Bullosa

Gene therapy developer, Abeona Therapeutics, announced that the FDA has granted Regenerative Medicine Advanced Therapy designation to EB-101, a gene-corrected autologous cell therapy product for patients with recessive dystrophic epidermolysis bullosa (RDEB). Abeona`s EB-101 product is an autologous, ex-vivo gene-corrected cell therapy in which the COL7A1 gene is inserted into a patient`s own skin cells (keratinocytes) for the treatment of the underlying disease in Recessive Dystrophic Epidermolysis Bullosa. The EB-101 program has
Pharmaceutical Business News

Celgene to buy Juno for $9 billion to boost CAR-T expertise

(Reuters) - Celgene Corp announced a $9 billion cash buyout of Juno Therapeutics Inc on Monday as it moves to cement its position as a key player in a new range of cancer therapies. The offer of $87 per share for the 90 percent of Juno that Celgene does not own sent Juno’s stock soaring 27 percent to $86.31 in premarket trading. Shares of Celgene fell 1 percent to $101.60. The two
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Merek’s KEYTRUDA Improved Overall Survival in Patients with Non-small Cell Lung Cancer

Merck announced that the pivotal Phase 3 KEYNOTE-189 trial investigating KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with pemetrexed (Alimta) and cisplatin or carboplatin, for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS). Based on an interim analysis conducted by the independent Data Monitoring Committee, treatment with KEYTRUDA in combination with pemetrexed plus
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Gilead to buy Kite Pharma in $11.9 billion deal

Reuters -- Gilead Sciences agreed to buy Kite Pharma in a $11.9 billion deal on Monday, as it looks to fuel growth with an emerging class of cancer immunotherapies that are expected to generate billions. Gilead will pay $180 per share in an all-cash deal, representing a 29.4 percent premium over Kite's Friday close. Kite's shares were trading up at $178.15 before the bell. Santa Monica, California-based Kite is developing
Neurology Pharmaceutical Business News

Data Showing Anti-Addictive/Pain Relief Benefits of Cannabinoids to be Presented at Upcoming Society of Neuroscience Meeting

Data recently obtained from Nemus Bioscience's research and development partner, the University of Mississippi (UM) will show the superiority of the NEMUS proprietary analogue of CBD, NB2222, versus plant-derived CBD in ameliorating pain in a validated mouse (murine) model of chemotherapy-induced peripheral neuropathy using an opioid as an active comparator.  The data was accepted for a presentation at the 2017 Annual Meeting of the Society of Neuroscience to held in
Pharmaceutical Business News

Forge Therapeutics Raises $15M Series A Financing to Develop First Novel Gram-Negative Antibiotic in Decades

Forge Therapeutics, Inc., a biotechnology company discovering first-in-class antibiotics using a breakthrough drug discovery platform, announced today the completion of a $15M Series A financing. The round is led by MagnaSci Ventures, with participation from Evotec AG, Alexandria Venture Investments, MP Healthcare Venture Management, Red Apple Group, and WS Investments. Forge has used its enabling technology to identify a novel LpxC inhibitor effective against multi-drug resistant bacteria ‘superbugs,’ and the
Pharmaceutical Business News

Sangamo Therapeutics and Pfizer Announce Collaboration for Hemophilia A Gene Therapy

Sangamo Therapeutics, Inc. and Pfizer Inc. announced this week, an exclusive, global collaboration and license agreement for the development and commercialization of gene therapy programs for Hemophilia A, including SB-525, one of Sangamo's four lead product candidates, which Sangamo expects will enter the clinic this quarter. "Sangamo brings deep scientific and technical expertise across multiple genomic platforms, and we look forward to working together to advance this potentially transformative treatment
Pharmaceutical Business News

Licensing Agreement for the Development of Drug to Treat Rare Pediatric Disorder Announced

A new treatment in development looks to treat rare condition that robs approximately 20,000 US children per year of their ability to speak. Q BioMed Inc.  and ASDERA LLC announced a licensing agreement that provides Q Biomed with the worldwide exclusive rights to ASDERA’s ASD-002, which is being developed to treat a rare pediatric nonverbal disorder. Among the more than 60,000 US children who develop autism spectrum disorders (ASD) every
Pharmaceutical Business News Radiopharmaceuticals

Q BioMed Gears up for Production of Cancer Pain Palliation Drug with Commercial Launch Expected in Q2 2017

Q BioMed Inc, a NYC-based biomedical acceleration and development company has begun process validation for the manufacturing of a non-narcotic analgesic treatment for pain associated with metastatic bone cancer. The drug, a generic Strontium Chloride 89 injection, provides long-lasting relief for patients suffering from debilitating bone pain due to metastatic cancer, typically caused by advanced-stage breast, prostate or lung cancer. It has been proven to provide a long-term effect --
Cell Therapy Clinical Trials Pharmaceutical Business News

Athersys Gets Nod from PMDA in Japan to Start Trial for the Treatment of Ischemic Stroke with MultiStem®

Athersys, Inc. got a major nod from Japan’s Pharmaceutical and Medical Devices Agency (PMDA) review of the Clinical Trial Notification (CTN), allowing the commencement by HEALIOS K.K. (Healios) of a confirmatory clinical trial evaluating the safety and efficacy of administration of MultiStem®, Athersys’ novel cell therapy product, for the treatment of ischemic stroke in Japan (also designated by Healios as HLCM051 in Japan). In accordance with the regulatory system in
cancer Pharmaceutical Business News

Q BioMed Closes on Licensing Agreement for FDA Approved Drug – vows no price hike

Q BioMed Inc., a New York-based biotechnology acceleration company recently acquired a FDA approved generic drug, Strontium Chloride ("SR89"). This licensed radiopharmaceutical agent is indicated for the treatment of pain associated with metastatic bone cancer. SR89 provides long lasting relief for patients suffering from bone pain due to metastatic cancer, typically caused by advanced-stage breast, prostate or lung cancer. The drug is preferentially absorbed in bone metastases, it has been