Search Results for “Roche” – Page 21 – media

Pfizer taps Samsung Biologics in long-term biosimilar production deal worth $411M

South Korea’s Samsung Biologics has captured a $411 million contract to manufacture biosimilars for pharma giant Pfizer.Under the deal, Samsung has pledged “additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio covering oncology, inflammation, and immunology.” The company described the deal as a “long-term” arrangement. Pfizer’s biosimilar portfolio features copycats to Roche’s cancer trio of Rituxan, Avastin and Herceptin plus biosimilar versions of Johnson & Johnson’s Remicade and Amgen’s Neupogen. The Samsung partnership will likely also include production of Pfizer’s biosimilar to AbbVie’s Humira, The Korea Herald reports, citing industry experts. AbbVie recorded $21.24 billion in sales of Humira last year. Amgen is already marketing a Humira copycat, but Pfizer and many other players are set to enter the market this year. In a financial filing, Samsung Biologics put the value of the Pfizer deal at $411 million, making it the biggest of its nature for the company and ...
- Source: drugdu
- 118
- June 11, 2023
Biosimilars ‘Fulfilling Their Promise’ of Lowering Biologic Prices

By Tristan Manalac Pictured: Cancer patient in bed looking out window / iStock, Ridofranz The entry of biosimilars promotes healthy market competition. It can reduce the prices of branded biologic medicines, according to a new study from the University of Southern California’s Leonard D. Schaeffer Center for Health Policy & Economics. The study, published online Tuesday in the journal Health Affairs, focused on Genentech’s (Roche) breast cancer treatment Herceptin (trastuzumab) and its five biosimilar competitors that entered the U.S. market starting in 2019: Amgen’s Kanjinti, Viatris’ Ogivri, Pfizer’s Trazimera, Teva’s Herzuma and Organon’s Ontruzant. Study results showed that when Herceptin’s first biosimilar competitor—Kanjinti—hit the market, its average price dropped around 21%, from $101 to $80 per 10 mg. By the second quarter of 2022, toward the end of the study’s analysis period, biosimilars maintained an average sales price of 28% to 58% of Herceptin’s pre-competition average sales price. “Trastuzumab is ...
- Source: drugdu
- 201
- June 9, 2023
Merck’s Keytruda, Novartis’ Kisqali face their moment of truth in early-stage cancers

Two cancers studies are slated to grab significant attention at the upcoming American Society of Clinical Oncology 2023 annual meeting, and each could lead to a major label expansion for the companies involved. With KEYNOTE-671, Merck is looking to shake up how nonmetastatic non-small cell lung cancer (NSCLC) is treated by testing Keytruda both before and after surgery. For its part, Novartis will elaborate on the postsurgery data for Kisqali in early breast cancer from the NATALEE trial. When the company said the trial met its endpoint, investors sent the Big Pharma’s stock price up by 8% in a single day. Before the official data revelations on June 2 for NATALEE and June 3 for KEYNOTE-671, Fierce Pharma gathered expectations for the two studies from oncology leaders at Penn Medicine and MD Anderson Cancer Center plus market analysts at multiple firms. The NATALEE study could open a market that’s worth ...
- Source: drugdu
- 119
- May 30, 2023
BMS pitches Breyanzi as the first CAR-T for CLL. But will a single-arm trial persuade the FDA?

CAR-T therapies have been around for six years, but it was only in January that Bristol Myers Squibb unveiled the first positive readout for such a personalized immunotherapy in chronic lymphocytic leukemia (CLL), the most common form of leukemia, from a pivotal multicenter study. In new data released Thursday, Bristol Myers Squibb said that Breyanzi eradicated signs of cancer in 18.4% of patients with heavily pretreated CLL or small lymphocytic lymphoma (SLL). The phase 1/2 trial coded TRANSCEND CLL 004 has therefore met its primary endpoint. Among those who achieved a complete response, the median duration of response wasn’t reached after a median follow-up of 21.1 months. No patients in that group experienced disease progression or deaths by the data cutoff. The results will be presented during the 2023 American Society of Clinical Oncology annual meeting on June 6. Bristol released the findings ahead of the meeting Thursday. Breyanzi’s complete response data “are remarkable and ...
- Source: drugdu
- 151
- May 27, 2023
AbbVie’s Rinvoq scores its 7th FDA nod, this one for Crohn’s disease

In developing immunology treatment Rinvoq, AbbVie is employing the same game plan it used to make predecessor Humira a megablockbuster. And the company seems to be getting better at it.Thursday, AbbVie scored its seventh FDA approval for Rinvoq in a span of less than four years, getting the JAK inhibitor across the finish line as a treatment for Crohn’s disease. A look at Humira’s approval history shows that AbbVie has become more efficient in adding indications to its immunology blockbusters. After Humira was initially blessed in 2002, it took AbbVie 10 years to get the TNF blocker endorsed for its seventh disease type. Coincidentally, Rinvoq’s new FDA approval came hours after the U.K.’s National Institute for Health and Care Excellence signed off on the drug for Crohn’s disease. This is the second gastroenterology indication for Rinvoq after it won approval for ulcerative colitis in March of last year. Rinvoq’s first ...
- Source: drugdu
- 126
- May 21, 2023
In Rare Move, CMS Fines 2 Hospitals for Price Transparency Violations

The Centers for Medicare & Medicaid Services appears to be enforcing its price transparency rule more seriously. The agency recently fined two hospitals for alleged violations of the rule. Last week, CMS issued fines to Frisbie Memorial Hospital in Rochester, New Hampshire and Kell West Regional Hospital in Wichita Falls, Texas. The former was fined $102,660, and the latter received a $117,260 fine. These fines are only the third and fourth penalties issued by CMS since its price transparency rule took effect on January 1, 2021. The other two came nearly a year ago, in June 2022 — Northside Hospital in Atlanta was fined $883,180 and Northside Hospital Cherokee in Canton, Georgia was fined $214,320. CMS’ rule aims to make hospitals’ pricing data more accessible to patients so they can compare costs and make more informed decisions about the healthcare services they choose. The law requires all hospitals to post their gross charges, payer-specific negotiated charges, de-identified minimum negotiated charges, de-identified maximum negotiated charges and cash prices on their ...
- Source: drugdu
- 133
- April 29, 2023
Drugmakers take sides in Amgen, Regeneron fight over antibody patents

Christopher Newman Editor “This is a showdown about whether the most valuable patents in the entirety of the patent system are valid,” one law expert said. The nearly decade-long patent feud between Amgen and rivals Sanofi and Regeneron has divided the biopharmaceutical industry, with drugmakers taking different sides in a U.S. Supreme Court case that could have far-reaching effects. At issue are patents for powerful cholesterol-lowering medicines known as PCSK9 inhibitors. Regeneron and Sanofi brought the first, Praluent, to market in 2015. Amgen followed one month later with a similar medicine, called Repatha. The drugs work by boosting liver cells’ ability to hoover up LDL, or “bad,” cholesterol. Amgen has long claimed Sanofi and Regeneron infringed on patents it secured for Praluent. The fight has slowly winded its way through the U.S. legal system to reach the Supreme Court. There, judges could disrupt the $160 billion-per-year market for antibodies by deciding how broadly ...
- Source: drugdu
- 171
- April 25, 2023
FDA, citing safety concerns, places partial hold on Merck KGaA’s MS drug

Dive Brief: The Food and Drug Administration told Merck KGaA not to give an experimental drug for multiple sclerosis to new patients and to pause treatment for study participants who have been on it for less than 70 days amid concerns about possible liver damage. Regulators acted after laboratory tests suggested the livers of two patients might have been adversely affected by the drug, known as evobrutinib. However, neither patient exhibited symptoms and their liver enzyme levels returned to normal after they stopped taking the medicine, Merck KGaA said Wednesday. The German drugmaker had already fully enrolled a Phase 3 study known as Evolution, and that program will continue as planned because all the patients have already had received the medication for at least 70 days. Results are still expected in the fourth quarter. Dive Insight: Evobrutinib is part of a class of drugs known as BTK ...
- Source: drugdu
- 200
- April 13, 2023
Is Parkinson’s disease, ‘world’s fastest growing brain disease,’ mostly preventable?

Researchers warn that a colorless chemical known as trichloroethylene (TCE) — which has been used to dry-clean clothes, degrease metals and decaffeinate coffee — may be linked to the dramatic increase in Parkinson’s disease (PD) cases. They recently published a series of seven cases in the Journal of Parkinson’s disease that illustrate TCE’s harmful health effects and the potential PD association. “TCE is associated with a 500% increased risk of Parkinson’s disease,” lead author Dr. Ray Dorsey, professor of neurology at the University of Rochester in New York and author of “Ending Parkinson’s Disease,” told Fox News Digital. The chemical reproduces the features of the neurological disease in laboratory animals. It impairs the function of the energy-producing parts of cells called mitochondria, which are known to be damaged in Parkinson’s disease, Dorsey added. Widespread applications of TCE TCE was first synthesized in the lab in ...
- Source: drugdu
- 152
- March 30, 2023
NICE questions value and efficacy of five Covid-19 drugs with rejection

This week, NICE rejected five major Covid-19 therapies due to high costs and uncertainties in clinical evidence. The UK’s National Institute for Health and Care Excellence (NICE) has published a draft guidance that does not recommend the use of five major Covid-19 therapies. This news came as many organisations and patient advocacy groups have been campaigning for the adoption of some of the rejected drugs for several months, amidst concerns about access to medicines in the UK. The therapies with a negative appraisal included three anti-Covid-19 antibodies; Regeneron Pharmaceuticals’ Ronapreve (casirivimab +imdevimab), GSK’s Xevudy (sotrovimab) and, AstraZeneca’s Evusheld (tixagevimab + cilgavimab). Between November 5 and November 12, a total of 20,588 people have reported testing positive for Covid-19 in England, according to government data. This number is likely an underestimation given the lack of testing amongst the population. Furthermore, in that same period, 3,407 patients were admitted to a hospital in the country for severe cases of Covid-19. ...
- Source: drugdu
- 150
- March 17, 2023

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