Search Results for “ Shire” – Page 4 – media

Roche scores—again—in hemophilia drug patent case against Takeda

In a patent case centered on two rival hemophilia medicines, Roche’s Genentech unit has scored its second straight win. After a U.S. district court last year ruled in favor of Roche and invalidated a patent held by Takeda’s Baxalta unit, the U.S. Court of Appeals for the Federal Circuit reaffirmed the ruling. In the decision, U.S. Circuit Judge Timothy B. Dyk wrote that in order to be valid, patents must describe inventions “in such full, clear, concise and exact terms” so that any skilled person can make and use the same product “without undue experimentation.” In this case, Baxalta’s patent describes an antibody that binds to a protein that’s key to enable blood clotting. In its appeal, Baxalta argued that skilled practitioners can use a screening process that doesn’t amount to undue experimentation. But the circuit court shot down this argument, supporting the decision that the patent should be invalidated. ...
- Source: drugdu
- 188
- October 1, 2023
Takeda settles antitrust lawsuit over gout drug Colcrys after trial kicked off

Takeda has managed to close one of the antitrust cases that have been hanging over the company. The Japanese pharma giant has inked a settlement with drug wholesalers who accused the company of using anti-competitive deals to delay generic entry to its gout drug Colcrys, a court filing shows. The exact terms of the deal were unclear. Takeda declined to comment. The lawsuit lasted for about two years. A group of wholesalers, including big names such as AmerisourceBergen, filed the antitrust claims in federal court in Pennsylvania in August 2021. The case centers on patent settlements that Takeda reached in 2015 and 2016 with several generic drug manufacturers around their generic versions of Colcrys. Other defendants in the lawsuit include Endo’s Par Pharmaceutical, Amneal and Teva, through its acquisition of Watson Laboratories. Rather than selling its own product, Par agreed to make an authorized generic Colcrys by paying Takeda royalties, ...
- Source: drugdu
- 204
- September 25, 2023
analysts

Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up their portfolios.During second quarter earnings calls, many heavy-hitters—including Johnson & Johnson, Bristol Myers Squibb and Merck—expressed urgency in their quest for deals. With so many buyers in competition, sellers are finding offers that are more attractive. For example, Merck’s $10.8 billion proposal to acquire Prometheus in April came at a 75% premium. In July, Biogen’s $7.3 billion deal for Reata represented a 59% markup. “There’s been such a consistent pick up in momentum in anything above a billion [dollars],” Cody Powers, an M&A expert with ZS Principal, said in an interview. “I think we’re back on the gravy train of where we were a couple of years ago in terms of premiums.” In 2019, the industry ...
- Source: drugdu
- 117
- September 11, 2023
Amid shortage, FDA clears several generics of Takeda’s popular ADHD drug Vyvanse

After 16 years on the market, Takeda’s blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. The med, which is also approved for binge-eating disorder, has been in short supply since June due to a “manufacturing delay compounded by increased demand,” the company said in a statement earlier this summer. Now, generics may soon help ease the supply situation. On Aug. 25, the FDA cleared many copycats of the drug. The now-approved generics range in dosage from 10 mg to 70 mg and come in capsule and chewable forms. Manufacturers such as Teva, Sun Pharmaceutical, Actavis, Mylan, Hikma and others have cleared the agency’s regulatory bar with their generics. It’s not clear whether any of the companies have actually launched their copycats in the U.S. Takeda’s patents on its branded version expired Aug. 24. Whenever they debut, the generics will surely be welcomed by patients. A 100-day ...
- Source: drugdu
- 126
- September 1, 2023
In Talc Defense, Johnson & Johnson Sues 4 doctors Over Their ‘Junk Litigation Opinions’

As Johnson & Johnson awaits a decision on its second attempt to resolve talc lawsuits through a bankruptcy ploy, the company is attempting another legal tactic to free itself from those liabilities—suing doctors who say that its iconic baby powder can cause cancer.In federal district court in New Jersey, J&J’s talc subsidiary LTL Management has filed two suits against four doctors who authored studies that described a link between J&J’s talc-based products and cancer. Last week, J&J filed suit against New Hampshire physician Richard Lawrence Kradin and Virginia doctors Theresa Swain Emory and John Coulter Maddox. In a separate suit in May, J&J sued New York physician Jacqueline Miriam Moline. In the most recent suit, J&J claims that the three doctors cited 75 people with malignant mesothelioma who had been exposed to cancer-causing asbestos only by using Johnson’s Baby Powder or another J&J talc product, Shower to Shower. ...
- Source: drugdu
- 108
- July 18, 2023
With Iveric Bio buyout, Astellas CEO Naoki Okamura acted on the company’s mantra to be ‘aggressive’

Earlier this year, when Astellas announced that Naoki Okamura was taking over as CEO, the Japanese company said that 2023 was the right time for it to “go on the aggressive to further stimulate growth.”It took Okamura less than a month into his tenure—which began April 1—to act on the company’s game plan. On April 29, he struck the largest acquisition in Astellas’ history, a $5.9 billion buyout of Iveric Bio. With the New Jersey-based biotech two months away from an FDA decision on its geographic atrophy (GA) eye disease candidate Zimura, Astellas hopes to become a major player in a new arena. “We had been closely watching the lead program for Iveric for a very long time, probably seven, eight years,” Okamura said in an interview with Fierce Pharma. “Because the modality of that project is very new to us, we were kind of hesitant to do any partnerships ...
- Source: drugdu
- 112
- June 15, 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
Royal Papworth Hospital robot for thoracic surgery to be UK first

A cutting-edge surgical robot is to be installed at the Royal Papworth Hospital in Cambridge. The Versius technology mimics human arm joints but has up to four times more rotation than the human wrist. It will be used in thoracic surgery, which includes heart and lungs, in a first for the UK. The device should make the surgery less invasive, improve outcomes and speed up patients’ recovery times, the hospital said. Staff at the hospital are to undergo a full training programme, with the first treatment due to start this spring. The technology is a partnership between the Royal Papworth and Cambridge-based company CMR Surgical. The robot is smaller than previous examples and is portable so it can be used in different theatres and for different specialities, which could include transplantation. “Our vision is to provide tomorrow’s treatment to today’s patients,” said Tim ...
- Source: drugdu
- 124
- March 30, 2023
Second wave of COVID-19 in UK has reached “critical” stage, says study

Caused by the highly contagious pathogen, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the feared but expected the second wave of coronavirus disease 2019 (COVID-19) has already hit the UK. This can be seen in the current high prevalence of infection across the country. Thus, the virus is poised to take a high toll on the country’s public health – and ultimately many of its citizen’s lives – unless prompt containment measures are put in place, says a recent study published on the preprint server medRxiv.* The first wave of the pandemic in the UK occurred from March and April 2020, characterized by a high infection peak and then a steep and continuing decline in new infections that lasted until the beginning of August. From this point on, there has been a steady rise in infections, with the reproduction number (R) staying above 1, indicating a propagating epidemic. Increasing Prevalence ...
- Source: drugdu
- 197
- November 15, 2020
Covid-19
Easy Interoperability for all mHealth Apps

Several top tech companies such as Google, Amazon, Oracle, Microsoft, IBM and Salesforce have vowed to remove barriers which prevent customers from accessing their personal mHealth data whenever they need it. The announcement was made at the Blue Button 2.0 Developer Conference held in Washington D.C.
- Source: mHealth Intelligence
- 497
- August 15, 2018
digital health EMR Market Views mHealth

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