Teva (TEVA) Pharmaceuticals will postpone launching its version of Indivior’s opioid addiction drug until the resolution of a U.S. court case on different generic rival, according to Reuters. Dr.Reddy’s Laboratories (RDY) is engaged in a legal battle in the United States to re-launch a generic version of the Indivior’s Suboxone Film. Indivior expects full-year net revenues of $25M-$50M from its opioid addiction drug Sublocade
Wednesday, September 12, 2018
Bausch Health settlement for Xifaxan shores up key franchise, says BMO
Bausch Health settlement for Xifaxan shores up key franchise, says BMO Capital. After Bausch Health () announced a generic Xifaxan settlement with Teva’s (TEVA) Actavis unit, BMO Capital analyst Gary Nachman called it “a very positive outcome” that shores up the durability of one of the company’s key growth franchises. The analyst, who said Bausch’s significant debt load likely remains a cap on the stock, keeps a Market Perform rating on the shares but raised his price target to $24 from $22.
https://thefly.com/landingPageNews.php?id=2789459
US plans crackdown on e-cigarette firms citing ‘epidemic’ teen use
The US Food and Drug Administration is considering banning the sale of flavoured e-cigarettes, citing an “epidemic” of use among teens.
The proposal, announced on Wednesday, is part of a broader effort to curb teen use of the nicotine devices.
FDA chief Scott Gottlieb said: “The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end.”
The toughened approach comes after firms ignored prior concerns, he added.
“I’ve been warning the e-cigarette industry for more than a year that they needed to do much more to stem the youth trends,” he said.
“In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate, and the existential threat to these products.
“Well, I’m here to tell them that this prior approach is over.”
Takeda to pack up Illinois HQ, move to Boston
Japan’s Takeda Pharmaceutical Co Ltd said on Wednesday it plans to shut its U.S. headquarters in Deerfield, Illinois and move it to the greater Boston area, following the closing of its Shire Plc acquisition.
Takeda Pharmaceutical Co's logo is seen at its new headquarters in Tokyo, Japan, July 2, 2018. REUTERS/Kim Kyung-Hoon
The Deerfield site employs just under 1,000 people — about a fifth of its U.S. employees — and a number of them will be provided with job offers and/or relocation opportunities, a Takeda spokeswoman told Reuters on Wednesday.
The company did not provide specifics on what percentage of the affected employees may face job cuts.
“This move, while difficult, will allow closer collaboration across Takeda to best position our future pipeline for success. It will also simplify our existing Takeda U.S. operations,” the spokeswoman said.
In May, Takeda agreed to buy London-listed Shire for 45.3 billion pounds ($62 billion), a deal that will make the firm closer to becoming a top 10 global drugmaker.
https://www.reuters.com/article/us-takeda-pharma-headquarters/takeda-to-pack-up-illinois-hq-nearly-1000-workers-to-be-affected-idUSKCN1LS2EY
Regeneron continues New York expansion with $800M project, 1,500 jobs
Regeneron is supersizing a campus expansion in New York, investing $800 million and adding 1,500 jobs and winning a substantial tax break in the process.
The company will build out its second campus in Rensselaer, New York, adding manufacturing capacity, laboratory space and warehouse facilities and adding 1,500 jobs over the next seven years. The state is chipping in $140 million in incentives to help.
According to a spokeswoman, the first part of the project will include about 350,000 square feet of manufacturing space, 240,000 square feet for offices and labs and a 1,000-space parking garage. The campus is about 130 miles north of its headquarters in Tarrytown, New York.
The expansion is slated to take about seven years. This is a larger version of a previously announced expansion for the drugmaker which made its name with blockbuster eye treatment Eylea, but which has more recently added new-generation cholesterol fighter Praluent and rheumatoid arthritis drug Kevzara, both of which it shares with Sanofi.
“As our number of approved and investigational medicines continues to grow, our need for world-class manufacturing teams and facilities also increases,” CEO Leonard S. Schleifer, M.D., Ph.D., said in a statement.
The company, which will have about 7,000 workers in the state when the build-out is complete, has steadily grown there since it launched as a biotech startup in 1988. At the end of 2016, it announced it would buy its headquarters in Tarrytown so it could control its fate there. It paid $720 million for 150 acres, consisting mainly of office buildings and lab space. But the facility has room to grow, with development rights for more than 500,000 square feet of construction.
It has also rapidly built up a biologics manufacturing site in Ireland. Last year, it said it would invest another $100 million there creating 300 more jobs. The U.S. drugmaker, which now boasts the largest bulk biologics plant in a country that has attracted many large pharma, added a number of manufacturing suites to increase drug substance production capacity.
When Regeneron picked up the 400,000-square-foot former Dell computer plant in Limerick in 2013, short-term plans were to invest between $250 million and $300 million and hire 300 employees. Now it expects to have about 800 employees there by the end of the year, with a total investment of about $750 million.
https://www.fiercepharma.com/pharma/regeneron-continues-new-york-expansion-800m-project-1-500-jobs
The company will build out its second campus in Rensselaer, New York, adding manufacturing capacity, laboratory space and warehouse facilities and adding 1,500 jobs over the next seven years. The state is chipping in $140 million in incentives to help.
According to a spokeswoman, the first part of the project will include about 350,000 square feet of manufacturing space, 240,000 square feet for offices and labs and a 1,000-space parking garage. The campus is about 130 miles north of its headquarters in Tarrytown, New York.
The expansion is slated to take about seven years. This is a larger version of a previously announced expansion for the drugmaker which made its name with blockbuster eye treatment Eylea, but which has more recently added new-generation cholesterol fighter Praluent and rheumatoid arthritis drug Kevzara, both of which it shares with Sanofi.
“As our number of approved and investigational medicines continues to grow, our need for world-class manufacturing teams and facilities also increases,” CEO Leonard S. Schleifer, M.D., Ph.D., said in a statement.
The company, which will have about 7,000 workers in the state when the build-out is complete, has steadily grown there since it launched as a biotech startup in 1988. At the end of 2016, it announced it would buy its headquarters in Tarrytown so it could control its fate there. It paid $720 million for 150 acres, consisting mainly of office buildings and lab space. But the facility has room to grow, with development rights for more than 500,000 square feet of construction.
It has also rapidly built up a biologics manufacturing site in Ireland. Last year, it said it would invest another $100 million there creating 300 more jobs. The U.S. drugmaker, which now boasts the largest bulk biologics plant in a country that has attracted many large pharma, added a number of manufacturing suites to increase drug substance production capacity.
When Regeneron picked up the 400,000-square-foot former Dell computer plant in Limerick in 2013, short-term plans were to invest between $250 million and $300 million and hire 300 employees. Now it expects to have about 800 employees there by the end of the year, with a total investment of about $750 million.
https://www.fiercepharma.com/pharma/regeneron-continues-new-york-expansion-800m-project-1-500-jobs
J&J raises a flag in early-stage lung cancer with first-ever contest in the field
No question about it, the lung cancer field is hot—and chock-full of new drugs and combos. But there’s a dearth of treatments specifically for early-stage disease, and Johnson & Johnson is looking to crowdsourcing to bring in new ideas.
It’s doing that through its latest QuickFire contest at JLABS, the company’s internal life sciences incubator. The winner of the Lung Cancer Innovation QuickFire Challenge will earn a yearlong residency at JLABS @ Shanghai, the newest of its 11 labs around the world.
The challenge zeroes in on ideas that might “prevent, intercept and cure early-stage lung cancer,” said Avrum Spira, the global head of the initiative for J&J.
“A lot of companies are tackling late stage disease—that’s where most pharmaceutical companies and biotechs are going today,” Spira said. “There’s a huge unmet need to go earlier in the disease process if we want to prevent and intercept the disease and catch it at its earliest stage.”
JLABS is tapping companies and people around the world—already it’s received U.S., Canada and China hopefuls—in the contest that ends Sept. 21. There may be more than one winner, but the total prize award is $750,000, plus the JLABS @ Shanghai residency, which is optional. Why Shanghai? The country is, as Spira said, “ground zero of the lung cancer epidemic.” Of the 1.6 million deaths caused by lung cancer every year, more than 600,000 occur in China.
Mentoring is also part of the prize, as with all J&J QuickFire Challenges, and the winners will join the J&J network of educational in-person and online opportunities. The winning ideas remain in the winners’ possession, but J&J will help mentor and shepherd them along the way to market.
J&J has run QuickFire challenges for more than five years, accumulating hundreds of external partners across a swath of disease states and healthcare industry challenges.
“One of the reasons we started QuickFire challenges is it’s a way to crowdsource innovative tech and solutions out there and catalyze researcher, academics, technology and entrepreneurs to really think about technologies,” said Erika Kula, director, sourcing innovation for JLABS, adding, “It’s not just an opportunity for us to foster innovation, but also to let the market know that J&J is here to play in a particular area.”
Nemaura: Positive Interim Data from Glucose Monitor FDA Clinical Trial
Nemaura Medical Inc. (NMRD), a medical technology company developing sugarBEAT® as a non-invasive affordable and flexible Continuous Glucose Monitor (CGM) for use by persons with diabetes and pre-diabetics, today reported data from an interim analysis of the first of a number of planned studies in support of a submission to the U.S Food & Drug Administration (“FDA”) for approval of its sugarBEAT® product.
The interim results consisted of 25 patients, split approximately equally between Type I and Type II diabetics1. The study was conducted in a clinic setting, and blood samples were taken via a catheter every 15 minutes over a 12 hour period for 3 non-consecutive days, for a total of 75 patient days. Blood samples were measured using an Architect c8000 Laboratory Instrument.
9,371 data points were analysed in total, consisting of 4,630 and 4,741 paired data points analysed using 1-point and 2-point calibration respectively. The MARD (Mean Absolute Relative Deviation, @ 30%/30mg/dL) for the 1-point calibration was 12.19% (80% of all data), and for the 2-point calibration the MARD was 10.65% (88% of all data)). The results are in line with the company’s expectations, and compare favorably with competitor products.
SugarBEAT® is expected to launch in the UK in the coming months, and is expected to be marketed to all categories of diabetics, including Type 1, Type 2 and pre-diabetics. Continuous Glucose Monitoring (CGM) is estimated to have a global total addressable market worth $82Bn. The U.S. has the largest number of CGM users, where 2018 usage numbers are estimated at 630,000 insulin users, representing 2.6% of 24.6 million people who have been diagnosed with diabetes.2
Nemaura previously reported data from the home-use portion of the same study, whereby 121 matched pair points between the Blood Glucose Meter and sugarBEAT® were evaluated, which indicated 84.3% of the data points had an overall MARD of 10.63%, and an overall nominal MARD of 16.3% (compared with 14.8%, 16.3% and 18% for Eversense, Dexcom G5 and Abbott Libre Pro respectively1).
Completion of U.S. study and FDA submission is anticipated in Q1 2019, alongside poster presentation at the Advanced Technologies & Treatment for Diabetes (ATTD) conference in Berlin in February 2019 for the full in-clinic portion, which is designed to record approximately 16,000 matched data points.
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