Corium Receives FDA Approval of ADLARITY® (donepezil transdermal system) for Treatment of Patients with Alzheimer’s Disease

Original Source Boston, MA, March 14, 2022 – Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today the U.S. Food and Drug Administration (FDA) has approved Corium’s ADLARITY (donepezil transdermal system) as a treatment for patients with mild, moderate, or severe dementia of the…

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Senior Biopharma Executive Joins MMS Holdings as Principal Medical Director

CANTON, Mich. (3/10/2022) – MMS Holdings, a data-focused contract research organization (CRO), announced the addition of Robert Allen, MD, to its team as Principal Medical Director of Global Drug Safety and Pharmacovigilance. Bringing more than 20 years of pharmaceutical industry experience, Dr. Allen has worked at Parke Davis, Pfizer, Adolor, AstraZeneca, Wyeth, Scirex, Premier, and…

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Kalamazoo lab filled COVID testing void. As cases wane, it eyes next step.

KALAMAZOO—Visitors to the city’s downtown pedestrian mall may not notice that a door to an important link in Michigan’s $28 billion life sciences industry is tucked into a busy parking deck. This office is where Genemarkers recognized during the early weeks of the COVID-19 pandemic that its lab, which performed R&D testing for skin care products, could turn…

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Analytical laboratory makes lasting “Impact” on Midland

Original Post Not all heroes wear capes — some wear lab coats. Personal care products, pharmaceuticals, and medical devices need to be tested to ensure they meet industry standards for our safety. Think: anesthetics are delivered directly into the human body, so they must be uncontaminated; heart medications need to navigate through the body and…

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RTI Surgical Announces Spin Off of Businesses into Two Independent Companies

Original Source ALACHUA, Fla., Jan. 4, 2022 /PRNewswire/ — RTI Surgical, a global private label OEM company, announced today that the company will spin off its Metals business, creating two independent companies that are focused on the needs of customers and patients in their distinct market segments. Ownership of both companies will be retained by Montagu,…

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Neogen, 3M announce blockbuster merger to create ‘global leader’ in food safety

Original Source Lansing-based food and animal safety products manufacturer Neogen Corp. plans to combine with conglomerate 3M’s food safety business. The two companies say they signed a definitive agreement for a deal to create a new global food safety and security company valued at $9.3 billion. Shareholders at Neogen (Nasdaq: NEOG) would hold about 49.9 percent of the…

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uniQure and CSL Behring Announce Primary Endpoint Achieved in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B

~ Largest gene therapy study in hemophilia B achieved primary endpoint of non-inferiority in annualized bleeding rate after stable Factor IX (FIX) expression, assessed at 18 months following a single dose of etranacogene dezaparvovec ~   ~ Etranacogene dezaparvovec also achieved secondary endpoint demonstrating statistical superiority in reduction of annualized bleeding rate compared to baseline…

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Praxis Bioresearch Seeks Regulatory Strategy Support from MMS Holdings to Develop Therapeutics for Alzheimer’s Disease

SACRAMENTO, Calif. 10/28/2021 – MMS Holdings (MMS) – a data-focused CRO – provided regulatory strategy support to Praxis Bioresearch in the development of a therapeutic for apathy in Alzheimer’s disease. This comes as Praxis was awarded a $2.9 Million Fast-Track SBIR Grant to advance the company’s lead development candidate, PRX-P4-003. Experts at MMS provided regulatory…

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Local Entrepreneur Brings Medical Device Manufacturing software into 21st Century

Menlo Park Software Founder and CEO Rick Bollinger has begun an industry discovery campaign. He is interviewing manufacturing experts to explore their most pressing problems and how they deal with them. He says “medical device manufacture is a high-stakes industry”. It’s still using mainframe era software for product development and regulatory compliance. “what’s needed is 21st…

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Stryker buys Gauss Surgical for its AI tech that tracks blood loss during childbirth

Original Source Stryker has snatched up Gauss Surgical after being drawn to its artificial intelligence-powered platform for monitoring a patient’s blood loss during surgery as well as following cesarean sections and childbirth. The company’s Triton system uses a computer vision app and an iPhone to visually measure a person’s loss of blood by capturing images of sponges,…

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