Mayne Pharma (USA), Inc.

FDA investigators found bird droppings and feathers on certain air purification units and noted the walls surrounding some of Granules India’s manufacturing equipment “were not secured enough to prevent birds from getting inside the facility.” From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it.Earlier this month, Granules was slapped with a Form 483 from the FDA following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept. 6. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more.The FDA published the Form 483 on its website Tuesday.Drugmakers are subject to Form 483s when FDA inspectors discover “objectionable conditions” at a facility that could result in potential manufacturing violations. The write-ups are often followed by the more serious consequence of a warning letter if the company at fault fails to clean up its operations.One of Granules’ biggest offenses comes down to poor control over production records.The FDA noted that on the first day of its inspection, investigators witnessed three trucks “full of scrap materials” attempting to depart Granules’ plant. Upon digging into these scraps, the FDA found remnants of signed and dated manufacturing documents such as analytical balance printouts, handwritten worksheets and a “large number” of “uncontrolled papers” that had been “torn into pieces and crumpled.”When the FDA was doing a walk-through of Granules’ quality control laboratory, inspectors noticed cleaning personnel removing a large black “scrap bag” from the area. The bag, like the trucks, contained a “large number of torn and a few intact pieces of analytical balance printouts, pH meter printouts” and more, the FDA said in its write-up.The FDA concluded Granules’ quality control unit had been dropping the ball by documenting manufacturing data on “uncontrolled white paper” and later disposing of the documents by tearing them into pieces and throwing them into trash bags.Upon piecing together some of these scraps with the help of Granules’ employees, the FDA was told by the plant's quality unit management that the torn pieces contained records that “should not have been destroyed.”Elsewhere, Granules struggled to keep its facility clean, free of pests and adequately guarded against cross-contamination incidents, the FDA said.For one, Granules failed to clean equipment to effectively remove traces of drug substance from previous manufacturing runs, creating the potential for cross-contamination, FDA investigators noted in their report. Further, the FDA observed a buildup of white to off-white powdery materials along with water droplets, wet surfaces and material hinting at potential bacterial, fungal and mold growth inside air purification units.Upon inspecting the filters for some of these purification units, the FDA found they were “torn in many sections,” while Granules’ HEPA filters contained “apparent dust, powdery materials and wet surfaces.”Investigators also found bird droppings and feathers on certain purification units and noted the walls surrounding some of Granules’ manufacturing equipment “were not secured enough to prevent birds from getting inside the facility.”Granules isn’t the only company being written up by the FDA for its poor handling of data and quality issues.In a separate Form 483 handed down to a Biocon Biologics plant in India this summer, the FDA noted that the company both failed to back up and overwrote manufacturing data predating April 25, 2024, hindering the agency’s investigation. The FDA further chided Biocon for its failure to properly investigate batch discrepancies. The regulator pointed out that it found employees had “inappropriately changed set points for instruments” that affected monitoring alarms in a room used to produce a U.S.-bound drug product.“The investigation found these inappropriate changes were made as a quick fix instead of addressing frequent maintenance issues,” the FDA explained in the Form 483.The write-ups for Granules and Biocon come as part of a slew of Form 483s published on the FDA’s website this month.Elsewhere, the FDA also scolded Japan’s Taenaka Kogyo, India’s Gland Pharma and Spain’s Laboratorios Farmaceuticos Rovi for various production infractions. 

According to GlobalData, the migraine drugs market is set to be worth $18.6bn in 2030 globally. Credit: Krakenimages.com via Shutterstock. The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England. Aquipta is an oral calcitonin gene-related peptide receptor antagonist that is used for the prevention of both chronic and episodic migraines. In the final draft guidance that was released on 11 April, the drug is recommended as an option for the prevention of migraines in adults who have at least four migraine days per month, only if at least three preventive medicines have failed. The drug received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2023 following positive data from two Phase III clinical trials, ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which assessed a 60mg once-a-day dose of Aquipta in adults with episodic and chronic migraine, respectively. Data from both trialsshowed that Aquipta offered a substantial decline in mean monthly migraine days from baseline to 12 weeks. The treatment also provided decline from baseline in mean monthly headache days and acute medication days. This list price of Aquipta is £463.38 for 28 tablets, with the medication set to be made available on the NHS from next month. However, at first it will only be available from specialist doctors in secondary care settings, rather than from GPs. See Also: MorphoSys gets grant for novel compounds for treating diseases associated with methyl modifying enzymes Laboratorios Farmaceuticos Rovi gets grant for injectable composition for treating cancer, especially breast cancer The US Food and Drug Administration (FDA) first approved the treatment for episodic migraines in September 2021, but AbbVie expanded the drug’s label to include chronic migraines in April 2023. The drug’s European brand name is Aquipta but it is sold under the name Qulipta in Canada and the US. According to GlobalData’s Pharma Intelligence Center, Aquipta is forecast to generate $1.56bn in sales in 2030. GlobalData is the parent company of Pharmaceutical Technology. Migraines are intense throbbing headaches, often accompanied by symptoms like nausea, vomiting, and sensitivity to light and sound. Chronic migraines involve experiencing headaches on 15 or more days per month, with at least eight of those headaches meeting the criteria for migraine. Episodic migraines, on the other hand, occur less frequently, typically fewer than 15 days per month. Distinct migraine attacks last four to 72 hours if left untreated. According to GlobalData, the migraine market is set to be worth $18.6bn in 2030 globally. In June 2023, NICE also recommended Pfizer’s Vydura (rimegepant) to prevent episodic migraine attacks.

Key Hires in CMC/Technical Operations, Business Development, and Finance MALVERN, Pa.--(BUSINESS WIRE)-- Venatorx Pharmaceuticals, a private, pre-commercial pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections, announced expansion of its leadership team with three key industry veterans: Jason Burdette joining as Senior Vice President, CMC and Technical Operations: Armand Girard as Chief Business Officer; and Tamra Adams, and Chief Financial Officer. These appointments come as the Company expands its remit from pure R&D to encompass support of commercialization. "Jason, Armand and Tamra bring a breadth of experience that will be instrumental to Venatorx as we continue to advance our portfolio and maximize the value of our assets," said Christopher J. Burns, Ph.D., President and CEO of Venatorx. "These additions to our senior leadership team are critical to ensure we are prepared for our NDA resubmission and are strategically positioned for continued success." Jason Burdette – Senior Vice President, CMC and Technical Operations – Burdette started at Venatorx in late 2023 and is an experienced leader with more than 30 years in the pharmaceutical industry across process chemistry, formulation and process development, manufacturing, supply chain management, and technical operations. He joined Venatorx from Aimmune/Nestle Health Science where he was a Senior Vice President and Head of Technical Operations. At Aimmune/Nestle Health Science, Burdette was responsible for formulation and process development, analytical development, CMC, manufacturing science and technology, quality control, quality assurance, supply chain, and product distribution. Before this, he was the Senior Vice President of Technical Operations with Paratek Pharmaceuticals and over the years has worked at Eagle Pharmaceuticals, Shire with aaiPharma, Elan Pharmaceuticals, Sandoz, and Mylan Pharmaceuticals. Burdette earned a bachelor's degree in chemistry and an MBA from West Virginia University. Armand Girard – Chief Business Officer – Girard is a seasoned biopharmaceutical executive with multiple product approvals and launches over his 25 years of experience in strategic planning, corporate development, clinical development, and business development. He has extensive partnering experience having completed collaborations, licenses, acquisitions, and spinouts by and between leading pharmaceutical and biotech companies. Girard joined Venatorx from GlycoMimetics where he was the Chief Business Officer. At GlycoMimetics, he was responsible for corporate strategy, partnering, and managing the company's corporate and institutional alliances supporting the development of uproleselan. Previously, he was Vice President, Technical Assessment and Senior Director for Business Development at Shire Pharmaceuticals to build the product pipeline and support Shire's strategic venture arm through investments. He received his undergraduate degree from Lehigh University and an MBA from St Joseph's Haub School of Business Executive Pharmaceutical Marketing Program. Tamra Adams – Chief Financial Officer – Adams has over 25 years of financial management experience. Most recently, she was CFO at Antios Therapeutics, a clinical-stage biopharmaceutical company that was developing innovative therapies to treat and cure HBV. Adams helped lead a $107 million financing and was responsible for IPO readiness, including filing the S-1. Before joining Antios, she founded Accounting Concepts, Inc., a firm that provided CFO, accounting, and financial services to emerging growth companies in the biopharmaceutical and information technology industries. Before that, Adams was the Senior Financial Executive at Silverstorm Technologies and began her career at Ernst & Young, followed by Goldman Sachs. She received her undergraduate degree from the State University of New York at Albany and received her CPA license in New York State. About Venatorx Pharmaceuticals, Inc. Venatorx is a private, late-stage clinical pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections. Venatorx’s lead program, cefepime-taniborbactam, is a clinical-stage antibiotic that successfully completed a Phase 3 study in adults with complicated urinary tract infections (cUTI), including pyelonephritis. In October 2022, BARDA awarded a contract of up to $318M for development and procurement of cefepime-taniborbactam for the treatment of melioidosis and multi-drug resistant infections. Venatorx is also developing an oral antibacterial, ceftibuten-ledaborbactam (formerly known as VNRX-7145), for the treatment of cUTI, including pyelonephritis, caused by certain bacteria in adult patients with limited treatment options; this product is completing Phase 1 and will advance directly to a global Phase 3 cUTI clinical trial. For more information about Venatorx and its anti-infectives portfolio, please visit . Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical development of Venatorx Pharmaceuticals’ product candidates.