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Pharmafile 04/24/2019 06:33
The Pharmaceutical Research and Manufacturers of America (PhRMA) trade lobbyists have spent near record levels on lobbying in the first three months of 2019. According to disclosures filed to Congress, the US lobby group spent $9.91 million in the first quarter of 2019. The figures show a 50% increase on the final quarter of 2018, as spending increased from $6.03 million in the last three months of last year.
Pharmafile 04/24/2019 05:58
AbbVie has revealed that its interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab-rzaa) has received marketing authorisation in the US from the FDA in the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. According to the company, Skyrizi produced "high rates of durable skin clearance" in two Phase 3 clinical trials.
Pharmafile 04/24/2019 05:57
US firm Eli Lilly has agreed to sell the Chinese rights to two of its antibiotics, Ceclor (cefaclor) and Vancocin (vancomycin), to Chinese firm Eddingpharm in a deal worth $375 million. Alongside the rights to the drugs the deal includes a manufacturing facility in the city of Suzhou, a city of 10.6 million to the west of Shanghai. According to Julio Gay-Ger, general manager of Lilly China, the transaction "will enable Lilly China to better focus our resources on the exciting new therapies that we are launching in our core therapeutic areas.".
Pharmafile 04/24/2019 05:28
Laurence Doud III, the former CEO of New York-based Rochester Drug Co-operative (RDC) – one of the largest drug distributors in the United States – has been charged with conspiring to distribute illegal narcotics and conspiring to defraud the United States. The charges against CEO Doud, chief compliance officer William Pietruszewski and the company itself, stand out as the first criminal charges to be filed against a pharma firm in relation to the opioid crisis. Image caption:. Image Credit: SHAWN DOWD/@sdowdphoto/. read more.
Pharmafile 04/24/2019 04:57
Israeli pharmaceutical firm Teva has announced its intention to terminate further development of its calcitonin gene-related peptide (CGRP) inhibitor Ajovy (fremanezumab) in the treatment of episodic cluster headaches after it became apparent that the drug is unlikely to meet its primary endpoint at Phase 3. Conclusions drawn from a pre-specified futility analysis of the Phase 3 ENFORCE study indicated that Ajovy would not adequately improve mean change from baseline in the weekly average number of cluster headache attacks during the 4-week treatment period, so the drugmaker has de. read more.
Pharmafile 04/23/2019 06:30
MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) has secured another approval from the FDA, this time as a first-line treatment in combination with Pfizer’s Inlyta (axitinib) in advanced renal cell carcinoma. The FDA made the decision based on Phase 3 data which showed that the combo significantly improved overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to Pfizer’s Sutent (sunitinib). read more.
Pharmafile 04/23/2019 06:02
Healthcare conglomerate Johnson & Johnson has agreed to pay $9.9 million to settle a Washington state lawsuit over the firm’s alleged misrepresentation of the risks of pelvic mesh implants. Attorney General Bob Ferguson sued the New Jersey-based firm in 2016 alleging its subsidiary Ethicon had violated the Consumer Protection Act by failing to tell patients of the risks of pelvic mesh implants. read more.
Pharmafile 04/23/2019 05:14
Patients with Parkinson’s have been able to walk after receiving electrical stimulation to their spines. A new treatment, developed by researchers in Canada, has helped restore movement in patients with chronic Parkinson’s disease by boosting electrical signals from their brains. Furthermore, the implant, developed by Professor Mandar Jog, from Western University in London, Ontario, was able to restore electrical feedback mechanisms, meaning that in the longer term, the treatment worked, even when the implant was turned off. read more.
Pharmafile 04/23/2019 04:41
An innovative malaria vaccine is set to be trialled in Malawi as part of large scale trials which will see the drug rolled out to 120,000 children in three African countries over the next four years. The trial of GSK’s Mosquirix (RTS,S) will see as many as 120,000 children in Malawi, Ghana and Kenya receive the vaccine. The trial is set to begin in Malawi’s capital Lilongwe on Tuesday of this week and will be rolled out in Kenya and Ghana in weeks to come. read more.
Pharmafile 04/18/2019 06:32
Novartis has revealed new interim data from its Phase 3 trial investigating the efficacy of its gene therapy Zolgensma (onasemnogene abeparvovec-xioi; AVXS-101) in the treatment of spinal muscular atrophy (SMA) Type 1 in patients under six months old. The data revealed that, following a one-time intravenous infusion of the therapy, Zolgensma "successfully transduced intended targets in the central nervous system (CNS) and provided widespread SMN expression comparable to tissue from unaffected individual.".
Pharmafile 04/18/2019 05:47
NICE has announced its decision to recommend UCB Pharma’s Cimzia (certolizumab pegol) for use on the NHS in England in the treatment of severe plaque psoriasis in patients who have failed to respond to, or are unsuitable for, other systemic treatments. The judgement also adds an additional treatment option for women before or during pregnancy, as well as while breastfeeding. read more.
Pharmafile 04/18/2019 05:31
Cannabidiol (CBD), one of 113 cannabinoids in cannabis plants, could be used to deliver medicines into the brain, according to research published in the journal Molecular Pharmaceutics . The non-psychoactive cannabinoid could act as a Trojan horse in helping drugs slip through the blood brain barrier (BBB) in the brains of mice, the research says. The BBB consists of a layer of tightly linked cells that line capillaries in the brain thus preventing substances from entering or exiting the brain. read more.
Pharmafile 04/17/2019 09:36
Insys Therapeutics has said Andrew Long will take over from Saeed Motahari as the company’s new CEO. The opioid drugmaker said the decision had come after Motahari agreed to step down from the position of President and CEO. The firm, who have faced legal issues over the marketing of their fentanyl based spray Subsys, have seen a series of successions in recent years after CEO Michael Babich was arrested in 2016. read more.
Pharmafile 04/17/2019 05:46
Jordanian firm MS Pharma has entered into an agreement to acquire 100% of the outstanding shares of Greek company Genepharm. The deal is expected to close by the end of April. Genepharm, a company which develops, manufactures and out-licenses high value, generics, has a strong portfolio alongside an extensive network of 223 customers across 70 countires around the world. The acquisition expands MS Pharma’s geographic footprint, which at the moment is mainly focused in the Turkey, the Middle East and Africa. read more.
Pharmafile 04/17/2019 05:30
Akcea Therapeutics has shared the news that Tegsedi (inotersen), its antisense oligonucleotide (ASO) inhibitor of human transthyretin (TTR) production, has been recommended by NICE for use on the NHS in the treatment of stage 1 or stage 2 polyneuropathy with hereditary transthyretin amyloidosis (hATTR). hATTR is a rare condition caused by abnormal formation of the TTR protein and aggregation of TTR amyloid deposits in the body’s tissues and organs.

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