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12.02.22
New Reimbursement Rules Will Likely Impact Digital Health and Telemedicine
On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued the 2023 Physician Fee Schedule (PFS) Final Rule. CMS publishes a PFS annually so as to make changes in federal healthcare reimbursement and policy. PFS changes often spill over into the private sector, as private payors typically consult the PFS when evaluating their own payment and policy arrangements.
Client Highlights
11.29.22
Wilson Sonsini Advises Cajal Neuroscience on $96 Million Series A Financing
On November 29, 2022, Cajal Neuroscience Inc., a biotechnology company integrating human genetics, functional genomics, and advanced microscopy to discover novel targets and therapeutics for neurodegeneration, launched with the completion of approximately $96 million in Series A funding. Cajal is uniquely focused on the mechanistic, spatial, and temporal complexity of neurodegeneration, integrating deep expertise in neuroscience, neuroanatomy, and computational biology with state-of-the-art technologies for high-throughput functional validation. The financing was led by The Column Group and Lux Capital, with additional participation from Two Sigma Ventures, Bristol Myers Squibb, Evotec, Alexandria Venture Investments, Dolby Family Ventures, and other investors.
Client Highlights
11.09.22
Wilson Sonsini Advises Inscopix on Its Acquisition by Bruker
On November 8, 2022, Bruker Corporation, a developer, manufacturer, and distributor of high-performance scientific instruments and analytical and diagnostic solutions, announced it acquired Inscopix, Inc., a neuroscience pioneer and market leader of miniaturized microscopes, known as miniscopes. The miniscope technology was originally developed at Stanford University. Wilson Sonsini Goodrich & Rosati advised Inscopix on the transaction.
Client Highlights
10.14.22
Wilson Sonsini Advises Enliven Therapeutics on Merger with Imara
On October 13, 2022, Enliven Therapeutics, a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, and Imara announced that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. Wilson Sonsini Goodrich & Rosati is advising Enliven on the transaction.
Alerts
8.29.22
Prescription Drug Provisions in the Inflation Reduction Act of 2022
The Inflation Reduction Act of 2022 (the Act)1 includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, such as allowing the U.S. Department of Health and Human Services (HHS) to negotiate prices for certain high-cost Medicare covered drugs (including small molecule drugs and biologics) and to implement the negotiated prices starting in 2026 (starting initially with 10 Part D drugs and ramping up over time to 20 Part D or Part B drugs), inflation rebates for Part D and Part B drugs, Medicare Part D redesign and a new manufacturer discount program aimed at lowering the out-of-pocket (OOP) costs for beneficiaries, and add-on Medicare Part B payments for biosimilar products.
Client Highlights
8.17.22
Wilson Sonsini Advises Obsidio on Its Acquisition by Boston Scientific
On August 15, 2022, Boston Scientific Corporation announced the acquisition of Obsidio, Inc., a privately-held company that has developed the Gel Embolic Material (GEM) technology used for embolization of blood vessels in the peripheral vasculature. Specific terms of the transaction have not been disclosed.
Alerts
7.06.22
California Enacts Strict New Rules on Packaging Materials
On June 30, 2022, California Governor Gavin Newsom signed into law SB 54, putting into place some of the nation’s strictest, far-reaching regulations on packaging materials. The legislation mandates significantly reduced use of plastic packaging for products sold, distributed, or imported into the state of California. Furthermore, SB 54 puts into place new recycling rate requirements with the stated goal of keeping plastic waste levels under control. Governor Newsom praised the legislation’s ambitious scope, stating, "California won’t tolerate plastic waste that’s filling our waterways and making it harder to breathe. We’re holding polluters responsible and cutting plastics at the source." Despite this rhetoric, it will likely prove challenging for industry participants to comply with key provisions, highlighted below:
Client Highlights
7.01.22
Wilson Sonsini Advises Kedalion Therapeutics on Acquisition by Novartis
On June 30, 2022, Novartis announced that it acquired Kedalion Therapeutics and its AcuStream technology, an innovative device that may have the potential to facilitate precise dosing and accurate delivery of certain topical ophthalmic medications to the eye. Wilson Sonsini Goodrich & Rosati advised Kedalion on the transaction.
Kedalion is a clinical-stage, venture-funded ophthalmic drug company based in Menlo Park, California. In November 2021, Kedalion Therapeutics announced the completion of its Series B financing led by Novartis, which included an exclusive option to acquire the company and its AcuStream technology.
Kedalion is a clinical-stage, venture-funded ophthalmic drug company based in Menlo Park, California. In November 2021, Kedalion Therapeutics announced the completion of its Series B financing led by Novartis, which included an exclusive option to acquire the company and its AcuStream technology.
Alerts
6.22.22
FDA Issues Guidance on Importing Drugs from Canada
On May 25, 2022, the U.S. Food and Drug Administration (FDA) issued a guidance document intended to help pharmacists and wholesale drug distributors understand and comply with its final rule regarding the import of certain prescription drugs from Canada. The 2020 final rule, titled "Importation of Prescription Drugs," implemented Sections 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with the goal of reducing the cost of covered products to American consumers without compromising public health and safety.
Alerts
5.20.22
CDER Launches the ARC Program to Expedite Treatment Options for Rare Diseases
In May 2022, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) announced the launch of a new program for expediting the development of new treatment options for rare diseases—Accelerating Rare disease Cures (ARC) Program.1 The FDA considers a disease that affects fewer than 200,000 people in the U.S. a rare disease, and estimates that more than 30 million people in the U.S. are living with a rare disease.2 However, of the approximately 7,000 known rare diseases, less than 10 percent have an FDA-approved treatment available.3
Alerts
4.25.22
DOJ Civil Division's Consumer Protection Branch Features FDA Enforcement Actions in its First-Ever Annual "Recent Highlights" Report
Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October 2020 through December 2021 and gives some insight into the enforcement trends companies can expect in the future as CPB's enforcement activities continue to ramp up.
Client Highlights
4.14.22
Wilson Sonsini Advises Sierra Oncology on $1.9 Billion Acquisition by GSK
On April 13, 2022, GlaxoSmithKline plc (GSK) and Sierra Oncology, Inc. announced that they have entered into an agreement under which GSK will acquire Sierra Oncology, a late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare forms of cancer, for $55 per share of common stock in cash, representing an approximate total equity value of $1.9 billion. The per-share price represents a premium of approximately 39 percent to Sierra Oncology’s closing stock price on April 12, 2022, and a premium of approximately 63 percent to Sierra Oncology’s VWAP over the last 30 trading days. Wilson Sonsini Goodrich & Rosati advised Sierra Oncology on the transaction.
Sierra Oncology’s differentiated momelotinib has the potential to address the critical unmet medical needs of myelofibrosis patients with anaemia. In January 2022, Sierra Oncology announced positive topline results from the MOMENTUM phase III trial. The study met all its primary and key secondary endpoints, demonstrating that momelotinib achieved a statistically significant and clinically meaningful benefit on symptoms, splenic response, and anemia. Sierra Oncology is anticipating U.S. regulatory submission in Q2 of this year and EU submission in the second half of 2022.
Wilson Sonsini has also advised Sierra Oncology on a number of recent financing transactions, including public warrant and equity issuances.
Sierra Oncology’s differentiated momelotinib has the potential to address the critical unmet medical needs of myelofibrosis patients with anaemia. In January 2022, Sierra Oncology announced positive topline results from the MOMENTUM phase III trial. The study met all its primary and key secondary endpoints, demonstrating that momelotinib achieved a statistically significant and clinically meaningful benefit on symptoms, splenic response, and anemia. Sierra Oncology is anticipating U.S. regulatory submission in Q2 of this year and EU submission in the second half of 2022.
Wilson Sonsini has also advised Sierra Oncology on a number of recent financing transactions, including public warrant and equity issuances.