Laboratorios Farmaceuticos Rovi SA /Distribution Ops/

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.

Adam Glanzman/Getty Images Moderna, one of three companies to have a COVID-19 vaccine authorized in the U.S., isn’t resting on its accomplishments but is instead working to scale up production further and improve on its vaccine. One of the downsides of the vaccine initially was its cold-storage requirements. It is approved for storage at between 36 and 46 degrees F for up to 30 days and up to seven months at -4 F. Although that places some demands and limitations on healthcare providers, it’s a bit more manageable than the Pfizer-BioNTech vaccine, which requires storage at about -94 degree F, which requires specialized freezers. However, Moderna has indicated it is working on new formulations that could extend the refrigerated shelf life. New data from the company also supports the vaccine could be refrigerated safely for three months. In its press statement, Moderna noted that if the U.S. Food and Drug Administration (FDA) authorized the new storage protocols, it could “facilitate easier distribution to doctor’s offices and other smaller settings.” Moderna’s president, Stephen Hoge, said, “That might be a breakthrough that really matters in 2022 in Africa and across lower- and middle-income countries.” The company is also working on combining the COVID-19 vaccine with a seasonal flu vaccine. “In the same single shot, you get a high efficacy flu vaccine, the appropriate virus variant for that given year, and you walk into your CVS or go to your [general practitioner], you get one dose and you’re all set for flu and for COVID,” Moderna’s chief executive officer, Stephane Bancel, told Fortune editor-in-chief Clifton Leaf at Fortune’s 2021 virtual Brainstorm Health conference. Moderna also said it is increasing manufacturing capacity for the COVID-19 vaccine. The plan is to create up to 3 billion doses in 2022, which is more than double its previous projections. As part of the scale-up, it is also planning to increase 2021 vaccine manufacturing between 800 million and 1 billion shots, which is an increase from its lower-end projections of 700 million. The numbers will depend on how many doses of lower-dose formulations for booster shoots and immunizations for children are eventually produced. Moderna’s doses are 100 micrograms of vaccine substance for the standard shot now, but boosters and children’s doses may only use 50 micrograms. “As we look forward to next year, we just see so much need for primary vaccine, we are hearing it all over the world, and also boosters,” said Hoge. “So depending upon … how much the ordering that happens is third doses or pediatric doses at 50 micrograms, we could see up to 3 billion doses.” Moderna plans to double production at a drug substance facility in Switzerland run by Lonza Group AG and increase output in Spain owned by Laboratorios Farmaceuticos ROVI SA by more than double. Factories in the U.S. will increase production by more than 50%. The company is also in late-stage discussions with other manufacturers. Earlier in April, it announced manufacturing contracts with Sanofi SA and Catalent. The U.S. government has agreed to increase its contract for Moderna’s COVID-19 vaccine by $236 million to about $1.25 billion. This is to cover additional costs associated with the various studies.