Enable Injections, Inc., a patient-centric drug delivery combination product company developing advanced wearable devices for subcutaneous delivery of high-volume therapeutics, today announced it has entered into development agreements with Apellis Pharmaceuticals, and most recently, UCB. Enable Injections currently has partnerships with five companies to deliver products that shift treatment to the home with easy, convenient self-administration of new large-volume drugs.

Read more: https://prn.to/2B3gYr6

Theravance Biopharma, Inc. and Mylan today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for YUPELRITM (revefenacin) inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). YUPELRI, a long-acting muscarinic antagonist (LAMA), is the first and only once-daily, nebulized bronchodilator approved for the treatment of COPD in the US. The companies expect YUPELRI to be available to COPD patients in the US before the end of the year. COPD is the third leading cause of death and the fourth leading cause of hospital readmissions in the US, affecting approximately 16 million Americans.

Read more: https://prn.to/2z6XBfo

"Excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea can be debilitating for patients and challenging for the medical community to diagnose and treat," said Jed Black, M.D., senior vice president, Sleep and CNS Medicine at Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine. "Jazz is committed to addressing unmet needs in sleep medicine by delivering meaningful treatment options."

"In the European Union, there is no approved treatment for people with excessive daytime sleepiness associated with obstructive sleep apnea, and people with excessive daytime sleepiness due to narcolepsy may benefit from the availability of new treatment options," said Professor Yves Dauvilliers, M.D., Ph.D. Head of Sleep and Wake Disorders at the University Hospital of Montpellier, France. "As the sleep medical community improves its understanding and diagnosis of these conditions, it is increasingly important that patients have multiple treatment options available to help them manage their condition more effectively."

Jazz has studied solriamfetol extensively via the Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) Phase 3 program, which was comprised of four studies that evaluated:

solriamfetol in EDS in adult patients with narcolepsy (TONES 2) or OSA (TONES 3 and TONES 4), and
the long-term safety and maintenance of efficacy for solriamfetol as a treatment for EDS in patients with narcolepsy or OSA (TONES 5).
Jazz presented long-term safety and maintenance of efficacy results from the TONES 5 Phase 3 study of solriamfetol in adult patients with EDS associated with OSA or with narcolepsy at the annual meeting of the Associated Professional Sleep Societies (APSS) in June 2018. TONES 2, 3 and 4 data were presented at APSS in 2017.

Read more: https://prn.to/2QAugRn

"This is the first new chemotherapy in forty years for adults with specific types of newly diagnosed secondary AML, a particularly aggressive cancer that typically affects older people and has a high mortality rate," said Dr. Nigel Russell, Professor of Haematology, Faculty of Medicine & Health Sciences at the University of Nottingham. "I am pleased that NICE has recognised the value of this medicine for adults with secondary AML. In time, it is expected to become the standard of care for this specific group of older AML patients."
Full details: https://prn.to/2Pe3ZLM

You’ve still got time to enter the eyeforpharma 2019 Awards and put yourself (or your colleagues) in the running to gain industry-wide exposure as a winner. It’s the only pharma awards that recognize what truly matters; value for patients and healthcare.

Due to many requests, the entry deadline has been extended - you now have until next Friday 16 November to submit your entries.

It’s free to enter, and winners are announced in front of over 1100+ pharma executives at either of eyeforpharma’s flagship Summits in Barcelona or Philadelphia.

Entries have already been submitted from the likes of Novartis, Pfizer, Janssen, Sanofi, BMS, and many more! Make sure you, or someone you know who’s deserving, is in the running to win!
Don’t miss out - enter the eyeforpharma Awards today:
https://eloqua.eyeforpharma.com/lp=21972?extsource=pharmemed

For more information contact Lucy Fisher, Awards Manager at eyeforpharma on lucy@eyeforpharma.com.

#awards #pharmaceutical #healthcare #medical #clinicalresearch

Amgen and Provention Bio, Inc., a clinical-stage biopharmaceutical company focused on immune-mediated diseases, today announced a licensing and co-development agreement for AMG 714, identified by Provention as PRV-015. AMG 714 is a novel anti-IL-15 monoclonal antibody being developed for the treatment of gluten-free diet non-responsive celiac disease (NRCD). Development efforts at Provention will be led by researchers with previous experience developing AMG 714.
Under the terms of the agreement, Provention will conduct and fund a Phase 2b trial in NRCD and lead the next phase of development and regulatory activities for the program. Amgen will make a $20 million investment coincident with Provention's next financing event, subject to certain terms and conditions.

Full details: https://prn.to/2Dtly4i

Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing innovative treatments to preserve vision in patients with diseases affecting the back of the eye, announced today that it entered into a strategic research collaboration with Beta Therapeutics Pty Ltd (Canberra, Australia) to develop new heparanase inhibitors for the treatment of retinal disorders with large unmet medical needs such as dry age-related macular degeneration.

Under the terms of the agreement Oxurion will have an exclusive option to license in the heparanase inhibitor program. Beta Therapeutics will receive an undisclosed upfront payment from Oxurion and is eligible to receive a payment upon exercising the licensing option, development, regulatory and commercial milestone payments, as well as royalties on net sales on the products developed under the partnership.

Full press release: https://www.prnewswire.com/news-releases/oxurion-and-beta-therapeutics-to-develop-new-heparanase-inhibitors-for-treatment-of-dry-amd-803387243.html

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in a medically supervised setting, announced today the approval of DSUVIA™ by the U.S. Food and Drug Administration (FDA). DSUVIA is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.
Full press release: https://www.prnewswire.com/news-releases/acelrx-announces-fda-approval-of-dsuvia-300743221.html

AstraZeneca has agreed to divest the prescription medicine rights to Nexium (esomeprazole) in Europe, as well as the global rights (excluding the US and Japan) to Vimovo (naproxen/esomeprazole) to Grünenthal. The medicines are outside AstraZeneca's three main therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory. Nexium has lost compound patent protection in the majority of global markets. Vimovo is patent protected in most European markets until 2025.
Nexium, a proton pump inhibitor developed by AstraZeneca, helps to reduce the amount of acid produced by the stomach in patients with gastrointestinal reflux conditions and ulcers. It has a number of indications, including the prevention and treatment of gastric ulcers induced by pain-relieving non-steroidal anti-inflammatory drugs (NSAIDs).

Read more: http://www.worldpharmanews.com/astrazeneca/4594-agreement-with-gruenenthal-for-rights-to-nexium-in-europe-and-vimovo-worldwide-ex-us

ViiV Healthcare has unveiled encouraging mid-stage data backing a long-acting formulation of its two-drug regimen cabotegravir and rilpivirine for the treatment of HIV.

According to long-term data from the Phase II LATTE-2 trial, the injectable regimen - administered either every eight weeks or every four weeks - showed “high rates of virologic response, long-term durability of virologic response and good overall tolerability,” the firm noted.

At 160 weeks, 90% and 83% of the patients receiving the injectable cabotegravir/rilpivirine every eight and four weeks, respectively, remained virally suppressed.

Read more: http://www.pharmatimes.com/news/encouraging_data_for_viivs_long-acting,_two-drug_hiv_therapy_1257551

Medidata and Pharm-Olam International have signed a new, five-year enterprise agreement to unify operational systems supporting study execution on Medidata Cloud.

Pharm-Olam previously used multiple systems and vendors, which led to duplicate data and silos requiring later integration. With Medidata, the global contract research organisation (CRO) will empower sponsors to accelerate drug therapy time to market by providing a single, unified view of clinical trials to all stakeholders.

Read more: http://www.pharmatimes.com/news/medidata_teams_with_pharm-olam_1256852

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, acted this week to target 465 websites that illegally sell potentially dangerous, unapproved versions of opioid, oncology and antiviral prescription drugs to U.S. consumers.
This effort was part of Operation Pangea XI, the eleventh annual International Internet Week of Action (IIWA). This is a global cooperative effort, led by Interpol, to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products sold on the internet.

Read more: http://www.worldpharmanews.com/fda/4586-fda-launches-global-operation-to-crack-down-on-websites-selling-illegal-potentially-dangerous-drugs

Bayer and Orion's darolutamide, a novel oral androgen receptor antagonist for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), has met its primary endpoint in the ARAMIS phase III clinical trial, shwoing that the drug significantly extended metastasis-free survival compared to placebo. The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were consistent with previously published data on darolutamide.

Read more: http://www.pharmatimes.com/news/bayer,_orion_drug_shows_strong_results_in_prostate_cancer_1256853

MSD’s Keytruda improved overall survival by up to 39% in first-line head and neck cancer, new results show.

Interim data from KEYNOTE-048 showed Keytruda monotherapy improved overall survival (OS) by 39% in patients whose tumors expressed PD-L1 with Combined Positive Score (CPS) greater-than or equal to 20, and by 22% in patients with CPS greater than or equal to 1, compared to the current standard of care.

In addition, Keytruda in combination with chemotherapy demonstrated improved OS by 23 percent regardless of PD-L1 expression.

Read more: http://www.pharmatimes.com/news/strong_results_for_keytruda_in_head_and_neck_cancer_1256643

Allergan is gearing up to file its oral CGRP receptor ubrogepant in the US for the treatment of migraine, following the success and completion of two safety studies.

The Dublin, Ireland-headquartered group said it plans to submit a marketing application for the drug in the first quarter of next year, and a believes it will be the first oral CGRP receptor antagonist submitted in the US for the acute treatment of migraine with or without aura.

The announcement rides on the back of findings from a one-year study that Allergan noted “continue to support positive safety and tolerability profile for ubrogepant”, and also a two-month hepatic safety study in healthy volunteers which demonstrated no signal of drug-induced liver injury.

This follows positive efficacy data released at the beginning of this year.

Read more: http://www.pharmatimes.com/news/allergan_to_file_ubrogepant_for_migraine_early_next_year_1256094

From November 1 specialist clinicians in the UK will be able to prescribe cannabis-derived medicinal products for the first time after a change in the law, the Home Office has confirmed.

The new law will not limit the types of conditions that can be considered for treatment and doctors will no longer need to seek approval from an expert panel in order for patients to access the medicines, it said.

Read more: http://www.pharmatimes.com/news/uk_doctors_allowed_to_prescribe_medical_cannabis_from_november_1255535

US regulators have approved Bayer/Janssen’s Xarelto to cut the risk of major cardiovascular (CV) events in people with chronic coronary or peripheral artery disease (CAD/PAD).

Until now, aspirin has been the standard of care for people with CAD and PAD, which affect 16.5 million and 10 million in the US, respectively, but research shows it is “simply not enough to address the underlying risk of blood clots that accompanies these conditions,” Janssen noted.

Xarelto, it says, is now the first and only Factor Xa inhibitor approved for patients living with these conditions.

Read more: http://www.pharmatimes.com/news/xarelto_approved_to_cut_risk_of_major_cv_events_in_cadpad_patients_1255527

Dublin, Ireland-based biopharma Carrick Therapeutics has licensed exclusive globl rights to develop and commercialise BTG’s targeted ovarian cancer drug BTG945.

The investigational drug, a combination of the targeting folate receptor α (FRα) and inhibiting thymidylate synthase, will now be referred to as CT900.

The small molecule compound – discovered by the Institute of Cancer Research - selectively enters cancer cells that over express folate receptor α (FRα) versus normal tissues and inhibits thymidylate synthase, leading to cell death.

Read more: http://www.pharmatimes.com/news/carrick_licenses_targeted_ovarian_cancer_drug_from_btg_1255359

Roche’s Hemlibra has been approved in the US for routine prophylaxis of bleeding episodes patients with haemophilia A without factor VIII inhibitors.

According to Roche, Hemlibra is the only medicine that can be self-administered subcutaneously once weekly, every two weeks or every four weeks for haemophilia A with and without factor VIII inhibitors.

“Many preventative treatment options for people with haemophilia A without factor VIII inhibitors require intravenous infusions several times a week. Even then, people can still experience bleeds, and there has been a need for more treatment options,” said Michael Callaghan, MD, haematologist, Children’s Hospital of Michigan, Detroit.

http://www.pharmatimes.com/news/use_of_roches_haemophilia_a_therapy_hemlibra_expanded_in_the_us_1254634

GlaxoSmithKline is to reverse its ban on paying healthcare professionals and key opinion leaders (KOLs), admitting that the policy has hit awareness of its products in the market.
The company’s then-CEO Andrew Witty introduced the measures in 2013, amid growing concern about pharma unduly influencing healthcare professionals and broader marketing misconduct. This included a $3bn fine imposed on GSK after it was caught promoting Advair off-label in the US, with a corporate integrity agreement imposed on it by US regulators.
GSK then sought to go above and beyond industry standards, and stopped paying healthcare professionals (HCPs) to speak about its products or disease areas, instead relying purely on its own clinical experts in order to prevent any hint of inappropriate influence.
But five years on, GSK says its unilateral move is to be reversed.

Read more: http://www.pmlive.com/pharma_news/gsk_to_reverse_no_kol_policy,_admitting_it_has_hit_marketing_1254345

Novartis announced that it has entered into a licensing and equity agreement with Boston Pharmaceuticals for the development of three novel anti-infective drug candidates that are part of the Novartis Infectious Diseases portfolio, which have the potential to address the need for new agents to treat antibiotic resistant Gram-negative infections.
Antibiotic resistance is widely recognized as a major public health threat and innovative candidates to combat drug resistant bacteria remain a critical unmet need. Both the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) have identified CRE and drug resistant Pseudomonads as serious threats that pose significant risk to human health.

"The need for new antibiotics that address drug resistant bacteria is clear and we are pleased to find a partner in Boston Pharmaceuticals who will dedicate the appropriate expertise and resources for the further development and commercialization of these programs," said Jay Bradner, M.D., President of the Novartis Institutes for BioMedical Research. "Drug discovery and development is a team sport and this agreement is part of our strategy to partner with like -minded innovators outside of our walls to further develop new innovative medicines focused on addressing global health challenges."
Read more: http://www.worldpharmanews.com/novartis/4559-novartis-licenses-three-novel-anti-infective-programs-to-boston-pharmaceuticals

Medherant has been awarded a grant by Innovate UK to help it upscale production of its TEPI Patch drug delivery system for clinical trials.

TEPI Patch technology enables the development of drug-in-adhesive patch products “with better adhesion and more efficient delivery of drugs through the skin over a prolonged period,” according to the firm.

Medherant's first product, an Ibuprofen TEPI Patch, is currently being assessed in Phase I clinical development with initial results expected in later this year.

Read more: http://www.pharmatimes.com/news/medherant_awarded_manufacturing_grant_from_innovate_uk_1254351

Bagsværd, Denmark, 1 October 2018 ¬- Novo Nordisk today announced plans to make the durable, connected insulin pens NovoPen® 6 and NovoPen Echo® Plus commercially available across key markets commencing in early 2019. In parallel, to support the future integration of its connected pens with broader digital health solutions, Novo Nordisk has signed new partnership agreements with leading diabetes technology companies that share Novo Nordisk's vision to improve the lives of people with diabetes: Dexcom, Glooko and Roche.
The partnerships aim to advance the solutions available for people living with diabetes and their healthcare professionals. Building upon its existing work with IBM Watson Health® and Glooko, Novo Nordisk aims to seamlessly integrate insulin dosing data from connected pen devices with its partners' open ecosystems and diabetes management solutions, such as data from continuous glucose monitoring (CGM) systems and blood glucose meters (BGM).

More details: https://www.novonordisk.com/media/news-details.2218400.html

Sanofi and Regeneron’s imunotherapy Libtayo has been cleared in the US to treat patients with certain forms of cutaneous squamous cell carcinoma (CSCC).

The decision, which follows a priority review, allows physicians to prescribe the drug to patients with metastatic CSCC or for those with locally advanced CSCC who are not candidates for curative surgery or radiation.

Advanced CSCC is the deadliest non-melanoma skin cancer, responsible for around 7,000 deaths in the US each year. There are currently no FDA-approved treatments for the condition.

Libtayo (cemiplimab) is an investigational human monoclonal antibody that targets the checkpoint inhibitor PD-1, and was granted Breakthrough Therapy designation status in the US last year.

Read more: http://www.pharmatimes.com/news/us_oks_sanofi,_regenerons_new_skin_cancer_immunotherapy_1254056

NHS England (NHSE) has agreed to provide funding for Janssen’s Symtuza, a once-daily darunavir-based single tablet regimen (STR) for the treatment of HIV in adults and adolescents.

This decision allows clinicians across England to routinely prescribe Symtuza(darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]) on the NHS for eligible patients.

Read more: http://www.pharmatimes.com/news/nhs_england_agrees_to_fund_janssens_symtuza_1254081