Latest news with #Pharmaceutical
Business Upturn
2 days ago
- Business
- Business Upturn
Medicamen Biotech secures USFDA nod for Bortezomib injection, marks its first ANDA approval
By Aditya Bhagchandani Published on June 3, 2025, 12:56 IST Medicamen Biotech Limited announced on June 3, 2025, that it has received its first Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (USFDA) for Bortezomib for Injection, 3.5 mg single-dose vial. This marks a critical milestone in the company's journey to expand into regulated markets, particularly the United States. The product is found to be bioequivalent and therapeutically equivalent to Velcade for Injection, a drug marketed by Takeda Pharmaceuticals U.S.A., Inc. The API (Active Pharmaceutical Ingredient) for the product was developed in-house and manufactured at Shivalik Rasayan, which holds a valid USDMF (Drug Master File No. 036171). The approval strengthens Medicamen Biotech's vertically integrated product portfolio and is a testament to its robust R&D capabilities and commitment to regulatory compliance and cGMP standards. The company emphasized that this achievement reflects its growing focus on global markets and quality-driven manufacturing. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information. Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
Yahoo
19-05-2025
- Business
- Yahoo
BioMarin agrees to acquire Inozyme for $270m
BioMarin Pharmaceutical has agreed to acquire Inozyme Pharma for $4.00 per share in a $270m all-cash transaction. This will enhance BioMarin's enzyme therapy portfolio by adding a late-stage enzyme replacement therapy, INZ-701. Unanimously approved by both companies' boards, the transaction will close in the third quarter of 2025, subject to regulatory clearance, tender offer completion and other customary closing conditions. INZ-701 is being evaluated to treat ectonucleotide pyrophosphatase/ phosphodiesterase 1 (ENPP1) deficiency, a rare genetic condition that impacts blood vessels, bones and soft tissues. This leads to increased cardiovascular mortality risk, particularly in infants, and severe rickets and osteomalacia in the paediatric and adult population. The first Phase III pivotal trial data for the therapy in children is anticipated in early 2026. Regulatory approval is expected in 2027. BioMarin will commence a cash tender offer to purchase all outstanding shares of Inozyme common stock. The board of directors of Inozyme has unanimously recommended that its stockholders tender their shares. The tender offer's completion is contingent upon standard closing conditions, including a majority of the outstanding Inozyme shares being tendered, the Hart-Scott-Rodino Antitrust Improvements Act waiting period expiry or termination, and other customary conditions. After the tender offer, a subsidiary of BioMarin will merge with Inozyme, and the remaining shares not tendered will be converted into the right to obtain the same $4.00 per share in cash. The acquisition is not dependent on financing. Goldman Sachs & Co is the exclusive financial advisor to BioMarin, with Cooley as legal counsel. Centerview Partners is Inozyme's exclusive financial advisor, and Goodwin Procter provides legal counsel. BioMarin Pharmaceutical CEO and president Alexander Hardy stated: "This acquisition brings to BioMarin an important medicine that has the potential to be the first treatment for children and adults with ENPP1 deficiency, improving care for people living with this serious condition. 'As BioMarin continues our transformation and delivers on our corporate strategy, we will continue to evaluate external innovation alongside internal innovation.' In 2024, the US Food and Drug Administration expanded the approval of BioMarin's supplemental biologics licence application (sBLA) for Brineura, an enzyme replacement therapy, to include children under three years of age with neuronal ceroid lipofuscinosis type 2 (CLN2) disease. "BioMarin agrees to acquire Inozyme for $270m" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
17-05-2025
- Business
- Yahoo
BioMarin to buy rare disease drugmaker Inozyme for $270M
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. BioMarin Pharmaceutical has agreed to spend $270 million to take control of a Boston-based drug company with complementary expertise in rare disease research. The all-cash deal, announced Friday, should close sometime between July and the end of September, having already received unanimous backing from the boards of both BioMarin and its target Inozyme Pharma. Once complete, the acquisition will hand BioMarin an experimental therapy that's currently being tested against uncommon disorders with names so alien they look as though a house cat walked across a laptop keyboard. Those disorders, known as ENPP1 deficiency and ABCC6 deficiency, can each be life-threatening. They arise when the body doesn't create enough of an enzyme that turns out 'inorganic pyrophosphate,' a molecule that keeps minerals like calcium from accumulating in soft tissues. Without that molecule, the resulting mineral buildup can cause bone weakness and pain, or artery blockages that lead to strokes, tissue death or multiorgan failure. Research has indicated that, in newborns and infants with the most severe forms of these deficiencies, the mortality rate is more than 50%. To date, the Food and Drug Administration has yet to approve any medicines for the diseases Inozyme is targeting. Inozyme — and now BioMarin — are hoping to change that with an enzyme replacement therapy code-named INZ-701. As the name suggests, INZ-701 is designed to do the job of that missing protein and spur the production of inorganic pyrophosphate. Results from a late-stage study of the therapy in children with ENPP1 deficiency are expected next year, meaning FDA approval could come as early as 2027. A Phase 2 study of patients with ABCC6 deficiency completed last summer, as did a Phase 1 experiment focused on a different blood vessel-calcifying disease that often accompanies kidney failure. To some analysts, the deal represents a bit of a shot in the arm for BioMarin, which last year trimmed its workforce, reduced some spending and culled several drug projects. Joseph Schwartz, of Leerink Partners, wrote in a note to clients that his team had been patiently waiting for BioMarin to do some business development, and is now 'pleased' to see the Inozyme deal come through. ENPP1 deficiency is very rare, with Inozyme estimating a global patient population of around 10,000. Yet Schwartz's team believes this treatment area could grow into a 'valuable' commercial opportunity for BioMarin. They 'think this is a step in the right direction and hope that this is just the beginning of [the company's] pipeline build out.' Analysts also highlighted how Inozyme can be easily folded into BioMarin's business, which already has other enzyme replacement therapies on the market like Vimizim, Naglazyme and Palynziq. The deal "fits like a glove," according to Schwartz, while Paul Matteis of Stifel described it as a "very strong strategic fit" in his own client note. BioMarin "has the commercial infrastructure and expertise to maximize the value of this late-stage asset," Matteis wrote. Others, though, weren't as bullish. While the deal "makes total sense," it's "unlikely to move the needle" for BioMarin as a whole, wrote RBC Capital Markets' Luca Issi. The company's share price was up a little more than 1% late Friday morning, to trade at almost $60. 'As BioMarin continues our transformation and delivers on our corporate strategy, we will continue to evaluate external innovation alongside internal innovation,' CEO Alexander Hardy said in a statement. 'We are in a strong financial position to bring in additional assets as we accelerate the development of medicines for patients with significant unmet need." Per deal terms, BioMarin will purchase all outstanding shares of Inozyme for $4 apiece. That's a roughly 180% premium from the $1.42 Inozyme shares were trading at on May 15. BioMarin had close to $1.3 billion worth of cash, cash equivalents and short-term investments by the end of March. The company also last summer laid out plans to bring in $4 billion in annual revenue by 2027. Recommended Reading BioMarin, having retrenched, outlines plans for growth
Yahoo
02-05-2025
- Business
- Yahoo
Cardinal Health Lifts FY25 EPS Outlook, Sees Growth Despite Tariff Risks
Cardinal Health Inc. (NYSE:CAH) on Thursday reported third-quarter 2025 adjusted EPS of $2.35, up 13% year over year, beating the consensus of $2.17. Sales remained flat at $54.9 billion, missing the consensus of $55.35 billion. Adjusted operating earnings increased 21% to $807 million. Third-quarter sales for the Pharmaceutical and Specialty Solutions segment remained unchanged at $50.6 billion. Third-quarter revenue increased by 20%, excluding the impact of the customer contract expiration, driven by brand and specialty pharmaceutical sales growth from existing and new customers. Segment profit increased 14% to $662 million in the third quarter, driven by contributions from brand and specialty products, MSO platforms (including GI Alliance), BioPharma Solutions (including Specialty Networks), and positive generics program performance, partially offset by the customer contract expiration. Also Read: Revenue for the Global Medical Products and Distribution segment increased 2% to $3.2 billion, driven by volume growth from existing customers. Segment profit increased 77% to $39 million in the third quarter, driven by the beneficial net impact of cost optimization initiatives. GMPD segment manufactures, sources, and distributes Cardinal Health brand medical, surgical, and laboratory products, as well as distributes medical, surgical and laboratory products known as national brand products Outlook: Cardinal Health raises fiscal year 2025 adjusted EPS from $7.85-$8.00 to $8.05-$8.15 compared to consensus of $7.96. Increased outlook for Pharmaceutical and Specialty Solutions segment profit to 11.5% to 12.5% growth, from 10% to 12% growth previously. Narrowed outlook for GMPD segment profit to $130 million to $140 million, from $130 million to $150 million previously. Despite the evolving macro environment conditions, Cardinal Health anticipates double-digit non-GAAP EPS growth in fiscal 2026. The company expects strong segment profit growth in Pharmaceutical and Specialty Solutions. In the face of the macro uncertainty, the company is updating its expectations for fiscal 2026 GMPD segment profit, which it now expects to be at least consistent with fiscal 2025 segment profit. The company will continue to assess opportunities and risks and plan to discuss its fiscal 2026 and beyond expectations at its upcoming Investor Day on June 12. Price Action: CAH stock is trading 2.30% higher at $144.53 at the last check Thursday. Read Next:Photo by deemerwha studio via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? CARDINAL HEALTH (CAH): Free Stock Analysis Report This article Cardinal Health Lifts FY25 EPS Outlook, Sees Growth Despite Tariff Risks originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
SBS Australia
28-04-2025
- Health
- SBS Australia
A ketamine-derived nasal spray improved Alexis' depression. It's being added to the PBS
A new medicine chemically similar to the drug ketamine could be a "step forward" for Australians living with the "constant battle" of depression. Thousands of Australians could be eligible to receive the nasal spray, called Spravato, which contains esketamine, at a subsidised rate through the Pharmaceutical Benefits Scheme (PBS) from 1 May. It's the first medicine to be PBS-listed specifically for treatment-resistant depression and will cost $31.60 per dose, or $7.70 for pensioners and concession holders. The medication is chemically similar to ketamine and would be offered to people experiencing treatment-resistant depression, like 34-year-old youth mental health researcher Alexis Hutcheon. Hutcheon started using the spray in 2022 after years of "frustrating" failed attempts with oral antidepressants. Hutcheon's journey with Spravato Hutcheon said her depression largely manifested as physical symptoms like gut issues, sleeping problems, and losing a lot of weight. It got to the point where she struggled to walk to the front door, let alone leave the house. "I was that depressed that my body was experiencing such horrible physical symptoms due to my deteriorating mental health," she told SBS News. Hutcheon went through years of trying oral antidepressants with limited to no success. "Some of them worked for a little bit, and then they didn't, and some of the side effects weren't something that I could handle, like no sleeping," she said. "If it doesn't work, you get this feeling like you want to give up, or you feel like it's your fault." READ MORE Allan says no depression treatments worked for him. Then he tried ketamine Hutcheon first tried Spravato during a clinical trial in 2022 and noticed positive changes almost "straight away". "I was always waiting for the moment where it stopped working, but it's been a number of years now, and things have improved and improved," she said. "Things haven't gone back to as bad as they were at all since I started using ketamine." How Ketamine works for treatment-resistant depression Ian Hickie, the co-director of the Brain and Mind Centre at the University of Sydney, has been working with patients who take Spravato. He told SBS News its PBS listing marks a "significant advance". "It's a really different compound to the available antidepressants we've had over recent years," he said. LISTEN TO New PBS listings offer timely and affordable treatment options for women SBS News 17/03/2025 06:22 Play Hickie explained it's the first PBS-supported drug that targets a different chemical in the brain called glutamate. "Internationally, about half the people with treatment-resistant depression demonstrated a significant improvement with this drug," he said. "In trials, I've personally been associated with in Australia, we have found the same thing in specialist clinics here." He said many patients have experienced a significant improvement in their quality of life, but cautioned it can cause some to feel "disoriented, disassociated, or quite unusual". Strict clinical regulations Ketamine therapy, along with other forms of treatment like psychedelic-assisted therapy, is highly regulated and is done in strict clinical settings. Studies have shown low doses of oral ketamine can treat post-traumatic stress disorder, and in tablet form, can reduce the symptoms of severe depression. These therapies are administered in hospitals and clinics under medical supervision. "You're in your own room and you're there for an hour and a half to two hours monitored by a clinician throughout the whole time," Hutcheon said. Hickie said the cost of attending clinics can be hundreds or even thousands of dollars, which can create a barrier for people wanting to try the nasal spray. "The cost of medical specialist care generally in Australia is very high, and that has meant access to these compounds to be difficult," he said. He said many mental health treatments are only offered privately, and he would like public hospitals to "step up" and provide the "novel" treatment. Despite the availability of ketamine therapy, illicit use of the drug is on the rise in Australia. Use of illicit ketamine on the rise A national survey of 740 people who regularly use illicit stimulants found over half had used non-prescribed ketamine. Fifty-three per cent of those surveyed last year used the drug, up from 49 per cent the year before, according to the University of New South Wales' Drug Trends program. The group releases annual surveys of hundreds of people who use illicit drugs living in each of Australia's capital cities. Dr Rachel Sutherland, lead of the Drug Trends program, said use of illicit ketamine was "infrequent" in a survey report for 2024. "It is important to note that most participants who had used ketamine reported infrequent use [i.e., less than monthly], although approximately one in 10 reported weekly or more frequent use," Sutherland said in the report. Hutcheon said there is more to do to help people access therapeutic ketamine. "Seeking help can be difficult, especially due to stigma. "Even though PBS-listing is one step forward, which we're so happy for, there will still be a number of people who won't be able to afford those private fees that occur to actually have the medication."
