Wednesday, January 22, 2025

Samsung Biologics Posts Record 2024 Sales, Operating Profit as it Goes Global

(1/22, In-Soo Nam, The Korea Economic Daily) ...With its 2024 revenue, Samsung became the first Korean biopharmaceutical firm with annual sales surpassing 4 trillion won. In the fourth quarter of 2024, its net profit rose 10.6% on-year to 321.5 billion won, while its operating profit fell 6.9% to 325.7 billion won. Quarterly sales gained 17% to 1.26 trillion won. In the regulatory filing, the company said it aims to achieve 2025 sales revenue of 5.57 trillion won...Samsung is now focusing on antibody-drug conjugates (ADCs), a promising area in oncology... Full

Johnson & Johnson Beats Earnings Estimates and Forecasts 2025 Growth

(1/22, Josh Nathan-Kazis, Barron's) ...Fourth quarter sales were $22.5 billion, slightly ahead of the FactSet $22.4 billion consensus estimate. Adjusted earnings for the quarter were $2.04 per share, ahead of the $1.99 per share estimate. Johnson & Johnson also laid out its expectations for 2025. It announced a reported sales guidance range with a midpoint of $89.6 billion, and a guidance range for operational sales, a non-GAAP measure that excludes the impact of currency conversions, with a midpoint of $91.3 billion... Full

ANI Maintains Course With Rare Disease Push In 2025

(1/21, Adam Zamecnik, Generics Bulletin) ...ANI Pharmaceuticals forecasts a roughly 25% growth in revenue for 2024, on the back of strong performance of its generic and rare disease businesses. As of now, the company's total net revenue guidance is projected between $739m to $759m, noted company CEO Nikhil Lalwani at this year's J.P. Morgan Healthcare Conference... Global Sub. Full

Henlius Builds On Abbott Biosimilar Partnership Gaining 69 Emerging Markets

(1/21, Urte Fultinaviciute, Generics Bulletin) ...This deal opens the door for Henlius to 69 emerging markets in Asia, the Middle East, Africa, Latin America, and the Caribbean. The Chinese firm anticipates launching the first products in 2027, with some still subject to completion of clinical development and registration. Under the agreement, Abbott will be responsible for the molecule registration and launch in these regions, while Henlius will manufacture the products in its Shanghai-based facility... Global Sub. Full

Takeda Tightens Reins On Early-Stage Investments, Looks to Expand Option Deals: R&D Head

(1/21, Gabrielle Masson, Fierce Biotech) ..."There's an evolution of our economic model that starts with [the] IRA (Inflation Reduction Act), and will get worse and worse and worse, but I think there's so many opportunities for us to counter that with new ways of working," Takeda's R&D head Andy Plump, M.D., Ph.D., told Fierce Biotech at the annual J.P. Morgan Healthcare Conference in San Francisco last week. The conference ended right as the U.S. government selected its second round of drugs up for Medicare price negotiations under the Inflation Reduction Act... Full

Hate Needles? Lilly's Weight-Loss Pill Could Get FDA Approval Next Year, CEO Says

(1/21, Lindsey Leake, Fortune Well) ...Eli Lilly & Co., the Fortune 500 pharma firm that manufactures weight-loss injection Zepbound (tirzepatide), has a comparable oral medication in the works that could be approved by the Food and Drug Administration as early as next year, according to CEO Dave Ricks... Full

J&J's Spravato Wins Expanded Label for Depression As Singular Treatment

(1/21, Alexis Kramer, Endpoints News) ...Johnson & Johnson's Spravato nasal spray received a label expansion on Tuesday, now approved as a standalone treatment for major depressive disorder in adults after two oral antidepressants fail, the company announced. The FDA's action makes Spravato the first-ever monotherapy for adults with treatment-resistant depression... Full

Catalyst Announces Sub-Licensee Pharma Launches FIRDAPSE in Japan

(1/21, RTT News) ...Catalyst Pharmaceuticals, Inc., a commercial-stage biopharmaceutical company, Tuesday announced that its sub-licensee, DyDo Pharma, has launched FIRDAPSE or amifampridine Tablets 10 mg in Japan for the treatment of Lambert-Eaton myasthenic syndrome or LEMS...DyDo Pharma, a wholly-owned subsidiary of DyDo Group Holdings, will distribute FIRDAPSE in Japan, where it was granted orphan drug designation. This launch marks a significant milestone in Catalyst's global expansion strategy, following prior approvals of FIRDAPSE in the U.S., Europe, and Canada... Full

Sunshine Biopharma Launches Olanzapine and Olanzapine ODT

(1/22, Indian Pharma Post) ...Sunshine Biopharma, a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals announced that its wholly owned Canadian subsidiary, Nora Pharma Inc., has launched two new generic prescription drugs..."We continue to strengthen our presence in the Canadian generic drugs market, currently estimated to be at $9.4 billion and projected to grow to $19.2 billion by 2032," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "We eagerly anticipate launching more products in 2025," he added... Full

Sanofi Issued Warning Letter for Genzyme cGMP Failures

(1/21, Ferdous Al-Faruque, Regulatory Focus) ...Investigators said Sanofi's methods, facilities, or controls for manufacturing, processing, packing, or holding failed to meet the agency's regulatory requirements. More specifically, the company was cited for failing to investigate all critical deviations in its manufacturing practices... Full

Sacklers Join Latest Deal to Settle Purdue Opioid Litigation

(1/21, James Nani, Bloomberg Law) ...Purdue Pharma LP's Sackler family owners have joined a proposed settlement that would allow the OxyContin maker to exit bankruptcy and put more than $6 billion toward resolving opioid-related litigation, court-appointed mediators said. With a faction of the Sackler family that had previously been holding out on a deal now on board, work continues on a reorganization plan, individual settlement agreements, and determining what the drugmaker will look like when it exits bankruptcy, the mediators said in a report filed Monday in the US Bankruptcy Court for the Southern District of New York... Sub. Req’d

Trump Urged by Democratic Senators to Keep Lowered Drug Prices

(1/21, Madison Muller, Bloomberg) ...Trump should use his deal-making skills to "flat out reject any request to end negotiations from giant pharmaceutical makers that have spent decades putting profits over patients," Democratic Senators Elizabeth Warren of Massachusetts and Ron Wyden of Oregon and Independent Bernie Sanders of Vermont wrote in a letter to the president seen by Bloomberg. "There is no legal basis for any pause, and allowing giant pharmaceutical companies to pressure you into one would dramatically increase costs for over 60 million Medicare beneficiaries and betray your own campaign promises," the lawmakers said... Full

Trump Reverses Biden Policies On Drug Pricing and Obamacare

(1/21, Berkeley Lovelace Jr., NBC News) ...On Monday, Trump signed a sweeping order aimed in part at reversing several Biden administration executive orders on health care, including efforts to lower the cost of prescription drugs for people on Medicare and Medicaid, enhancing the Affordable Care Act and increasing protections for Medicaid enrollees. The so-called initial rescissions order, according to the Trump White House, is aimed at Biden policies that it says are "deeply unpopular" and "radical."... Full

Deciphering Trump's Executive Order On Medicare, Medicaid Payment Models

(1/21, Cathy Kelly, Pink Sheet) ...Trump rescinded a Biden era executive order that led to the development of CMMI payment demonstrations involving cell and gene therapies in Medicaid, Medicare payments for accelerated approvals and capped copays for generics drugs in Part D. The executive order does not specifically target the demos and appears not to directly impact them so far. The administration may eliminate some demos, but the cell and gene therapy project, which is furthest along, could be the most likely to remain... Global Sub. Full

Trump's Executive Order Solidifies DOGE As Part Of White House Operations

(1/21, Maaisha Osman, Inside Health Policy) ...FDA, HHS and other health agencies will now have 30 days to create a DOGE team of at least four employees to work with the department to cut costs... Sub. Req’d

As Trump Takes Office, RFK Jr Faces Questions Over Generics

(1/21, Dave Wallace, Generics Bulletin) ..."Pharmaceutical companies are gaming the patent system to block competition from lower-cost generics, often in violation of antitrust law," [Senator Elizabeth] Warren sets out. "If confirmed as secretary of HHS, what plans do you have to crack down on patent abuses by the pharmaceutical industry?" In particular, Warren highlights that the US Food and Drug Administration and US Patent and Trademark Office are "engaging in initiatives that protect and promote marketplace competition and lower drug prices."... Global Sub. Full

Cassidy, Sanders Say PBM Reform A Priority For Health Committee

(1/21, Sigi Ris, Inside Health Policy) ...Senate health committee leadership will prioritize pharmacy benefit manager reform and lowering prescription drug costs by bolstering generic drug access this Congress, committee leaders said Tuesday (Jan. 21). The statements come after Sen. Mike Crapo (R-ID) recently said the Finance Committee under his helm will fight high drug costs by modernizing Medicare prescription drug benefits and reforming PBM business practices... Sub. Req’d

Novartis CEO Says Concerns On Trump Health Policy Are Overblown

(1/21, Naomi Kresge, Bloomberg) ...Moves by the incoming Trump Administration may be a boon to drugmakers, Novartis AG Chief Executive Officer Vas Narasimhan said, while concerns over vaccine policies and public health funding are "overblown." Novartis wants to work to reverse some of the previous administration's policies which had a "chilling effect on innovation," Narasimhan said in an interview. He cited former US President Joe Biden's Inflation Reduction Act, which permitted the government to negotiate drug prices... Full

Looming Tariffs Prompt Companies to Protect Supply Chains

(1/22, Isabel Gottlieb, Bloomberg Law) ..."We have clients who the tariffs could impact quite meaningfully," said Felicia Nowels, a partner at Akerman. "Hence the need to prepare with great detail and in advance so that on day one they are ready, no matter what mechanism is in place—and of course, we need to be prepared to be surprised." Despite his promise for day-one tariffs, Trump floated on Monday that he might impose 25% tariffs on Mexico and Canada, effective in February. He said Tuesday his threat to hit China with 10% tariffs on all imports was still on the table... Full

Who's Running The US FDA? Interim Team May Not Have Assumed Control

(1/22, Sue Sutter and Sarah Karlin-Smith, Pink Sheet) ...Sara Brenner, CDRH's chief medical officer for in vitro diagnostics, is expected to be named FDA acting commissioner. However, it is unclear if Brenner officially has assumed the post because her appointment has not been formally announced by the White House, which quickly moved to announce acting heads for other agencies. A handful of executive orders signed by President Trump on January 20, could lead to broader personnel changes at the agency... Global Sub. Full

Cancer & Blood Disorder Drugs Lead EU Innovative Drug Approvals In 2024: What's Next For 2025?

(1/21, Neena Brizmohun, Pink Sheet) ...Medicines containing a new active substance (NAS) approved for pan-EU marketing last year were again led by cancer drugs, with treatments for blood disorders following closely behind. Meanwhile, three NAS-containing drugs have been approved so far this year, and 12 other products are expected to be authorized shortly, having recently been recommended for approval by the European Medicine Agency... Global Sub. Full

China's Biotech Boom is Threatening US Drugmakers' Dominance

(1/21, Jared Whitlock, Endpoints News) ...Last week at the JP Morgan Healthcare Conference in San Francisco, the rise of Chinese biotechs was a major topic. "There has been a significant and fundamental shift in the last five years in terms of breadth, depth and quality of assets coming out of China, as you have management teams that have been trained in the United States or other developed countries that have gotten back to China," Gilead CFO Andy Dickinson said at the conference. As the Chinese industry has grown up, companies there have been able to compete in obesity, cancer and other novel parts of biotech... Full

India and US Can Strengthen Ties in Healthcare Says Pharma Leader

(1/21, Shalini Bhardwaj, News India Times) ...As the US remains the top market for the Indian pharmaceutical industry, experts in India are now expecting opportunities for collaboration in healthcare security and affordability following the new US administration under President Donald Trump, stated Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance...He further added that more opportunities can be explored in pharmaceutical research, development, and manufacturing... Full

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