Greenwich LifeSciences Phase IIb 5 Yr Data Shows 0% Recurrence of Breast Cancer

 Wed, December 9, 2020, 9:05 AM EST·9 min read

‒ Poster for GP2 Phase IIb clinical trial final efficacy analysis was presented during the 2020 San Antonio Breast Cancer Symposium (SABCS) today

‒ Phase IIb clinical trial was a prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites) trial led by MD Anderson Cancer Center

‒ Kaplan Meier analysis of disease free survival for patients treated with GP2 immunotherapy shows 100% survival (0% breast cancer recurrences, p = 0.0338) following surgery and Herceptin treatment over median 5 years of follow-up

‒ Company now preparing to enter a Phase III clinical trial to treat a similar population of moderate to severe (high risk T1, T2-T4) breast cancer patients

View the full release here: https://www.businesswire.com/news/home/20201209005460/en/

https://finance.yahoo.com/news/greenwich-lifesciences-announces-poster-presentation-140500263.html

Japan's Takeda says drug pipeline to lift sales to $48 billion in next decade

 

Japan's Takeda Pharmaceutical Co said on Wednesday its drug pipeline is poised to drive annual sales up by more than 50%, to 5 trillion yen ($48.01 billion) in the next decade.

Japan's biggest drugmaker is trying to turn the spotlight on its growth prospects after its $59 billion takeover of Shire Plc, completed last year. Since the merger, the company's shares have underperformed domestic and global peers as it focused on selling $10 billion in non-core assets to reduce debt.

"One of the questions that we've had to ask ourselves is, how can we help our investor base better understand our pipeline, and assume the same energy and enthusiasm that we have?" research and development president Andy Plump said in an online briefing to analysts and media.

The company outlined a wave of 12 new drugs planned for the next few years, including a dengue fever vaccine and its Orexcin narcolepsy drugs, which it expects could deliver $6 billion in annual sales.

The 5 trillion yen sales target by March 2031 compares with estimated revenue of 3.2 trillion yen this fiscal year.

"Takeda's management is keenly aware of its poor stock performance and would like analysts to take a more bullish view of its pipeline," Jefferies analyst Stephen Barker wrote in a research note. "But analysts may not be convinced until more data is available."

The Shire acquisition, completed in January 2019, expanded Takeda's pipeline and diversified its global sales. But it also saddled the drugmaker with a large debt pile.

The company reached its goal of asset disposals when it agreed in August to sell its Japanese consumer healthcare business to Blackstone Group.

Takeda's shares, down 6.5% this year, rose 1.2% in Tokyo trading versus a 0.9% gain in the broader market.

https://www.marketscreener.com/quote/stock/TAKEDA-PHARMACEUTICAL-COM-6491073/news/Takeda-Pharmaceutical-Japan-s-Takeda-says-drug-pipeline-to-lift-sales-to-48-billion-in-next-decad-31968628/

SIEMENS HEALTHINEERS Raised From Sell to Buy by Morgan Stanley

 Morgan Stanley's analyst Michael Jüngling increases his rating from Sell to Buy. The target price is being increased from EUR 37 to EUR 46.40.

https://www.marketscreener.com/quote/stock/SIEMENS-HEALTHINEERS-AG-42379342/news/SIEMENS-HEALTHINEERS-From-Sell-to-Buy-by-Morgan-Stanley-31970156/

FDA Ok's Lipocine's testosterone replacement therapy, tentatively

 

• The FDA has granted tentative approval to Lipocine's (NASDAQ:LPCN) Tlando, its oral testosterone product for testosterone replacement therapy in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary and hypogonadotropic hypogonadism
• The agency cited that Tlando is not eligible for final approval and marketing in the U.S. until the expiration of the exclusivity period previously granted to Clarus Therapeutics for Jatenzo, which expires on March 27, 2022.
• The FDA has also required Lipocine to conduct certain post-marketing studies.
• https://seekingalpha.com/news/3642889-fda-oks-lipocines-testosterone-replacement-therapy-tentatively

Lilly’s verzenio data shows decrease in breast cancer recurrence

 

• Eli Lilly (LLY +4.2%) has reported additional data from a pre-planned primary outcome analysis from Phase 3 monarchE trial evaluating Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET), for breast cancer. Data were presented at the Virtual San Antonio Breast Cancer Symposium.
• The study showed that Verzenio decreased the risk of breast cancer recurrence by 28.7% compared to standard adjuvant ET alone. This statistically significant improvement corresponds to a 3% difference in the two-year rate of invasive disease-free survival between arms (92.3% in Verzenio arm vs. 89.3%)
• Lilly will submit trial data to regulatory authorities by the end of this year.
• Earlier today, the company reported that tirzepatide showed significant A1C and weight reductions in patients with type 2 diabetes.
• https://seekingalpha.com/news/3642951-lilly-s-verzenio-data-shows-decrease-in-breast-cancer-recurrence

Thermo Fisher doubles global footprint for drug development, commercial manufacturing

 

• Thermo Fisher Scientific (NYSE:TMO) further expanded its footprint in North America and Europe for sterile drug product development and commercial manufacturing of critical medicines, therapies and vaccines.
• Thermo Fisher sites currently being expanded are: Greenville, NC.; Swindon, U.K.; and Ferentino and Monza, Italy; adding 15 development and cGMP commercial production lines. These projects are expected to be completed over the next two years and will create ~1,000 jobs.
• Additionally, company recently announced significant projects in Asia-Pacific, including a new sterile manufacturing facility in Singapore and a new integrated biologics and sterile drug development and manufacturing site in Hangzhou, China.
• "With these investments, we've nearly doubled our global footprint for drug development and commercial manufacturing, which allows us to support our customers with unmatched flexibility, expertise and scale at a time of unprecedented demand," commented Mike Shafer, senior vice president and president, pharma services.
• https://seekingalpha.com/news/3642916-thermo-fisher-doubles-global-footprint-for-drug-development-and-commercial-manufacturing

Asian nations could mandate COVID-19 shots for travelers, AirAsia chief says

 Governments in Asia could require inbound travellers to receive COVID-19 vaccinations, AirAsia Group’s Chief Executive Officer said on Wednesday, with such conditions expected to become a trend in the region.

“I foresee in Asia anyway, I think they won’t let anyone in without a vaccination,” AirAsia Group CEO Tony Fernandes said at a CAPA Centre for Aviation event.

Fernandes said airlines are not likely to set such requirements for travellers.

“It’s not up to the airlines to decide. It’s for governments to decide. It’ll be the country that’ll decide if they will allow people to come in if they are not vaccinated,” he said.

Aviation industry opposition to requiring mandatory COVID-19 vaccination for passengers has intensified as impending drug approvals trigger a debate over their role in air travel.

Qantas Airways was the first airline to say it will require a COVID-19 vaccination for passengers on future international flights, which are now mostly idle because of Australia’s strict border controls.

“We believe that vaccinations will be required for entry to many countries in the future. And for a period of time, parallel requirements of (being) vaccinated or pre-flight negative tests,” said Todd Handcock, the Asia Pacific president of Collinson Group, which owns Priority Pass airport lounges.

https://www.reuters.com/article/us-airasia-strategy/asian-nations-could-mandate-covid-19-shots-for-travellers-airasia-chief-says-idUSKBN28J0SN