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Body Image in Teens
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Reducing Social Media Use Significantly Improves Body Image in Teens & Young Adults

Editorial Team
  • March 9, 2023
  • 3 min read
Depression Therapy Device
Medical Devices

Sooma’s Depression Therapy Device Receives FDA Green Light

Editorial Team
  • March 9, 2023
  • 3 min read
Walgreens
Hospitals & Providers

Walgreens Opts Against Selling Abortion Pills in GOP-Controlled States After Legal Pressure

Editorial Team
  • March 9, 2023
  • 3 min read
Roche's Genentech filed a lawsuit against Biogen in federal court, alleging that Biogen owes extra patent royalties on sales of its wildly successful Tysabri treatment for multiple sclerosis and Crohn's disease. When Genentech created a method for producing antibodies forty years ago, several biopharma companies waited in line to license the technology. The invention, known as the "Cabilly patents" is named after scientist Shmuel Cabilly, and enabled Genentech and its parent firm Roche to construct a quasi-toll booth that produced approximately $1 billion in royalty payments per year.  The validity of these patents expired in 2018, but Roche is still attempting to recover the remaining royalties it believes are still pending. According to Genentech's lawsuit, even though Tysabri was sold years after it was manufactured using Genentech's patents, Biogen is still obligated to pay royalties. Roche said that Biogen had not paid royalties on its Tysabri since the end of 2018 in a breach of contract lawsuit filed in federal court in the Northern District of California and wanted a jury trial. When Tysabri was introduced in 2004, Biogen began to pay fees. According to court records, the agreement called for Biogen to pay a mid- to low-single-digit percentage on Tysabri sales in the United States and a "reduced royalty" on sales of the medication elsewhere in the globe. Payments were made every three months. Yet according to Roche, Biogen produced Tysabri and kept stockpiles of it, according to the standard practice taking place in the industry. Notwithstanding the fact that Tysabri sales occurred after 2018, according to Roche, it is still owed royalties on the drug that was accumulated before Cabilly's expiration. Roche stated in their complaint: “Because the process for manufacturing antibodies is complex, and the consequences of a stockout potentially catastrophic, it is customary for biopharmaceutical firms that make and sell therapeutic antibodies to stockpile at least several calendar quarters worth of product, and often more than that.” Tysabri, which produced more than $2 billion in revenue each of the previous two years, is one of Biogen's most successful medications. During the four-year period from 2019 to 2022, the sales of the medication were $7.9 billion. The case raises concerns about other businesses that were in a similar licensing agreement with Roche and may have ceased paying royalties after completing sales in 2018. Genentech issued a statement in which it claimed that the company is not commenting on the case as they are confident in the enforcement of the Cabilly patents, even though the litigation is still in process. Biogen did not comment on the case. Business between Roche and Biogen has not been affected by the dispute. A late-stage bispecific antibody called glofitamab is being researched for use against blood malignancies such as B-cell non-lymphoma, and Hodgkin's. Almost three months ago, Roche and Biogen reached an agreement for royalties on its possible commercialization. Also read, The recommended price range for Eisai’s Leqembi increased by ICER
Pharma

Genentech sues Biogen for royalties on blockbuster MS drug

Editorial Team
  • March 7, 2023
  • 3 min read
Apotex to recall glaucoma drug after sterility concerns  Apotex, Canada's largest generic drug maker, has announced a recall of six lots of brimonidine tartrate ophthalmic solution, which is used to treat glaucoma and ocular hypertension.  The recall comes after Apotex discovered cracks on the caps of certain brimonidine tartrate bottles, which could compromise the sterility of the drug and potentially cause unwanted side effects. Apotex reported no patient complaints or safety signals tied to the recall. The affected bottles were shipped across the United States between April 2022 and February 2023. Apotex is reaching out to wholesalers, distributors, warehouses, and pharmacies to track down the affected batches. The recall only pertains to brimonidine tartrate in the 0.15% presentation from Apotex. This is not the first time Apotex has faced regulatory scrutiny in the United States. In 2019, the company withdrew 31 of its generic drug approvals from the FDA after the regulator identified manufacturing issues at two plants in India. In 2021, Apotex initiated two recalls: one for the anticoagulant enoxaparin and another for three lots of 2-mg guanfacine extended-release tablets, used to treat attention deficit/hyperactivity disorder. Despite these regulatory setbacks, Apotex has enjoyed a relatively good run. Apotex has undergone a CEO switch and a price-fixing settlement, and the company sold itself to private investment firm SK Capital in September 2022. The terms of the sale remain undisclosed. At the time of the sale, Apotex employed approximately 8,000 people across more than 100 countries. The company has a significant footprint in India and Mexico, in addition to Canada and the United States. In 2019, Apotex was valued at around $3 billion. The pharmaceutical industry is no stranger to recalls. In recent years, several high-profile recalls have made headlines. In 2019, for example, Sandoz issued a recall of its prescription heartburn medication ranitidine after discovering that the drug contained a probable human carcinogen. In 2020, Mylan recalled several batches of its epinephrine auto-injectors, used to treat severe allergic reactions, due to a potential failure to activate. Recalls can have significant financial and reputational consequences for pharmaceutical companies. In addition to the cost of the recall itself, companies may face legal liabilities, lost revenue, and damage to their brand reputation. As such, many companies are taking steps to prevent recalls from occurring in the first place, including investing in quality control measures and improving their supply chain management. Brimonidine Tartrate Ophthalmic Solution is a medication that stimulates alpha-adrenergic receptors and is prescribed to reduce elevated intraocular pressure or IOP in individuals suffering from open-angle glaucoma or ocular hypertension. The drug has been found to be associated with a safety concern, which has prompted Apotex to recall six lots of the drug. The company has taken the step as a precautionary measure after it discovered cracks on the caps of certain bottles containing brimonidine tartrate.  The company is reaching out to wholesalers, distributors, warehousing chains, mail-order pharmacies, and long-term care pharmacies to identify the affected bottles, which were shipped between April 2022 and February 2023 across the United States. Also read, Amidst bacterial outbreak, FDA issues second warning to Delsam Pharma’s Artificial Eye Ointment
Supply Chain

Apotex to recall glaucoma drug after sterility concerns

Editorial Team
  • March 6, 2023
  • 3 min read
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