NYC Health + Hospitals Rejects Federal Funding Tied to New ‘Gag Rule’

Mayor Bill de Blasio, Deputy Mayor for Health and Human Services Dr. Herminia Palacio, and President and CEO of NYC Health + Hospitals Dr. Mitchell Katz today announced the City’s public health system will cease participating in the federal Title X program for as long as the “gag rule” is in effect. The rule prevents medical providers from sharing information and counseling about abortion to their patients. In a directive to all NYC Health + Hospitals personnel, Dr. Katz today instructed doctors and nurses to support patients on whatever pathway they choose, including providing referrals to abortion and reproductive health services.

In February 2019, the Trump Administration issued the federal “gag rule,” which bars health care providers who receive federal Title X funding from referring or counseling patients about their abortion options. A federal lawsuit – for which New York City filed an amicus brief – had been blocking the gag rule from taking effect. Last week, the Federal Court of Appeals in the Ninth Circuit vacated this injunction, allowing the gag rule to take effect immediately across the country. This would force doctors and medical providers who receive these federal funds for sexual and reproductive health to withhold information about legal abortions from their patients.

Rather than censor providers, NYC Health + Hospitals will reject $1.3 million in federal funding from the Title X program — which funds a range of family planning and related preventive health services — until the gag rule is lifted. The City will cover the lost Title X funds, and NYC Health + Hospitals will direct doctors and nurses to continue providing referrals to abortion and reproductive health services.

Mayor, NYC Health + Hospitals Reject Federal Funding Tied to New “Gag Rule”

Retrophin (RTRX) PT Raised to $41 at Canaccord

Canaccord Genuity analyst Michelle Gilson raised the price target on Retrophin (NASDAQ: RTRX) to $41.00 (from $37.00) while maintaining a Buy rating after the company announced the FDA has approved THIOLA EC 100mg and 300mg tablets for the treatment of cystinuria.

“While we are encouraged by the step forward in the regulatory process, an update on IP around the new formulation is anticipated 2H19 or later,” Gilson commented. “A positive update on IP would help to lift the overhang on generics development further, though would not prevent competition around the original formulation. We expect comparable pricing to original formulation, which should enable access to switching.”

https://www.streetinsider.com/Analyst+Comments/Retrophin+%28RTRX%29+PT+Raised+to+%2441+at+Canaccord+Genuity/15663433.html

Regeneron Libtayo OKed for Cutaneous Squamous Cell Carcinoma in EU

Libtayo is the only treatment approved in the EU for adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation

CSCC is one of the most common skin cancers worldwide and is especially difficult to treat in advanced stages

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has granted conditional marketing authorization for Libtayo^® (cemiplimab) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the only treatment approved in advanced CSCC in the European Union (EU).

“With no other medical treatments approved for advanced CSCC in the EU, Libtayo represents an important new option for patients affected with this advanced skin cancer who cannot be cured by surgery or radiation,” said Axel Hauschild, M.D., Ph.D., an investigator in the pivotal CSCC clinical program and Professor and Head of the Interdisciplinary Skin Cancer Center at the University Hospital Schleswig-Holstein in Kiel, Germany. “Results from the Libtayo pivotal trial are very encouraging and demonstrated substantial and durable responses following Libtayo treatment, including in the elderly and regardless of PD-L1 expression levels.”

Updated data from the registrational EMPOWER-CSCC-1 trial were recently shared at the 2019 American Society of Clinical Oncology Annual Meeting.

https://www.marketscreener.com/REGENERON-PHARMACEUTICALS-10649/news/Regeneron-Pharmaceuticals-Libtayo-cemiplimab-Approved-for-Advanced-Cutaneous-Squamous-Cell-Carc-28837939/

Lonza fills portfolio hole by buying Novartis drug bottling plant

Lonza Group is buying a drug bottling plant from Novartis in northern Switzerland as the Swiss drug ingredients maker fills a gap in its offering for drugmakers seeking to outsource production.

Novartis is selling the so-called “fill and finish” facility because its production lines had been underutilised.

Lonza has been building up its drug products services business for three years and has been weighing whether to buy a factory from a rival where it can put the finishing touches on injectible medicines, o
r build such a facility itself like it is doing now in Visp, Switzerland. [https://reut.rs/32272tu]

In buying Novartis’s 10-year-old plant in Stein, Lonza will be able to speed up work for customers seeking to take their injectible medicines quickly into the clinic and onto the market, in particular for smaller lots of medicines aimed at niche populations, a Lonza spokeswoman said.

“Buying rather than building also means we will be operational immediately with an experienced team,” said Hanns-Christian Mahler, Lonza’s head of drug product services who the company poached in 2016 from Roche to build up the business.

Lonza shares were up 0.7 percent at 0830 GMT, bringing their rise this year to 29 percent.

Lonza plans to keep the facility’s employees and will continue to produce for Novartis.

SEAMLESS FIT

“The acquisition of the sterile bottling plant in Stein fits seamlessly into Lonza’s strategy to expand its drug development, production and formulation business,” Zuercher Kantonalbank analyst Philipp Gamper wrote in a note to investors. Gamper has a “market weight” rating on Lonza shares.

Lonza previously expanded into packaging operations for drugs when it bought Capsugel in 2016 for $5.5 billion.

Novartis is selling the drug bottling plant that it built in 2009 after reviewing alternatives for its under-used production lines.

“The planned sale of the two buildings is the best option to ensure the further employment and development of our employees and the continuation” of the site, a Novartis spokesman said. “Lonza will produce drug product at the facility for Novartis as well as providing capacity for additional customers.”

This month, Lonza carved out its specialty ingredients operation which makes products such as anti-microbials for paint into a standalone business aiming to remedy problems there that have dragged on earnings.

Lonza has also sold a water care business as it seeks to expand its faster-growing biopharmaceuticals business.

https://www.marketscreener.com/LONZA-GROUP-2956013/news/Lonza-fills-portfolio-hole-by-buying-Novartis-drug-bottling-plant-28834841/

Principia Biopharma started at Buy by Wainwright

Target $55

https://www.benzinga.com/stock/PRNB/ratings

Boehringer Expands NASH R&D Pipeline With New Compound from Yuhan

• Boehringer Ingelheim focuses on the development of next generation NASH treatments that target all three key drivers of the disease – steatosis, inflammation and fibrosis
• Collaboration aims to develop first-in-class dual agonist (GLP1R/FGF21R agonist) for NASH
• Yuhan Corporation to receive up to USD 870 million in upfront and success-based development and commercialization milestones, excluding royalties

 Boehringer Ingelheim Pharmaceuticals, Inc. and Yuhan Corporation today announced a collaboration and license agreement for the development of a first-in-class dual agonist for the treatment of NASH and related liver diseases that combines GLP-1 and FGF21 activity in one molecule. The collaboration brings together Yuhan Corporation’s expertise in FGF21 biology, obesity and NASH with Boehringer Ingelheim’s pharmaceutical expertise and commitment to bringing innovative medicines to patients with cardiometabolic diseases.

https://www.biospace.com/article/releases/boehringer-ingelheim-expands-nonalcoholic-steatohepatitis-nash-r-and-amp-d-pipeline-with-new-first-in-class-compound-from-yuhan-corporation/

ZULRESSO for Treating Postpartum Depression Launched by Sage

Ligand Pharmaceuticals Inc. (NASDAQ: LGND) today announced that SAGE Therapeutics has launched ZULRESSO™ (brexanolone) injection, which was approved by the U.S. Food and Drug Administration (FDA) on March 19, 2019, and is the first and only treatment specifically approved for postpartum depression (PPD), one of the most common medical complications during and after pregnancy. ZULRESSO uses Ligand’s Captisol in its formulation. With this launch, ZULRESSO is the 11th FDA-approved drug to use Ligand’s patented Captisol technology.

ZULRESSO is administered via continuous intravenous (IV) infusion for 2.5 days under the supervision of healthcare providers in sites of care certified under the ZULRESSO Risk Evaluation and Mitigation Strategy (REMS) program. For more information on ZULRESSO, including the final product label, visit ZULRESSO.COM or ZULRESSOREMS.COM.

https://www.biospace.com/article/releases/zulresso-brexanolone-civ-a-product-for-treating-postpartum-depression-using-ligand-s-captisol-in-its-formulation-launched-by-sage-therapeutics/