As F-star starts its transition into a clinical stage company underpinned by two proprietary bispecific compounds due to enter clinic late 2019, Eliot Forster joins the company as CEO with plans to expand the company’s regulatory and clinical operations capabilities and raise new funds.

German Merck tells Scrip its quest to find a partner for its Bruton’s tyrosine kinase inhibitor evobrutinib should be helped by positive 24-week Phase IIb data in relapsing multiple sclerosis.

While cancer drug makers generally applaud the rare reimbursement decision in China, some have pointed to mounting and significant pressure to lower prices, while insiders say the real battle has only just began and that translating the coverage into commercial success will take much more effort.

Allogene launched a $324m IPO to fund development of its allogeneic CAR-T pipeline, bringing its 2018 fundraising total to $744m. Also, GW Pharma's $345m offering tops recent follow-ons.

Scrip caught up with several companies during the recent Cell and Gene Meeting on the Mesa, sponsored by the Alliance for Regenerative Medicine.

In an exclusive interview, one of the most direct CEOs in the industry, Regeneron’s Len Schleifer, clarifies his attitude to drug pricing and growing internal innovation.

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Venture Funding Deals column provides a comprehensive monthly review of emerging biopharmaceutical companies that have received venture funding. This month’s column covers deals announced August and September.

In a busy week, Carrick Therapeutics has added to its oncology pipeline, as well as bringing in Celgene deal maker George Golumbeski.

October has been a very good month for Ionis. Following US approval of Tegredi, it has now signed a potentially lucrative deal with existing partner Roche for another antisense drug, this time to tackle advanced dry AMD.

With partner CCHN, Alvotech will help finance construction of a biologics facility in Changchun, China. Novartis will work with Cellular Biomedicine to produce Kymriah for China, and will gain access to its CAR-T platform.

The two firms hope improvement in the six-minute walk test might be accepted by the US FDA as registrational endpoint for reldesemtiv in spinal muscular atrophy. Blackstone acquires Clarus, while Merck licenses TriNKETs from Dragonfly.

Cure Pharmaceutical is launching Sleep Stripzzz melatonin supplement delivered in a fast-dissolving oral strip. The company has bigger visions of using the CureFilm delivery method in CBD products and eventually Rx drugs.

The company will not commercialize an insulin glargine copy already tentatively approved by FDA as Lusduna, but says it remains committed to biosimilars in oncology and immunology.

Cipla’s global head (operations) Raju Subramanyam is leaving the firm to pursue his own ambitions. The exit has resulted in an interesting portfolio rejig at the Mumbai-based firm, known for its generally clear manufacturing compliance record.

Mylan's Kokino spoke with Scrip about what he called the successful launch of the company's first biosimilar in the US, a version of Amgen's Neulasta, the state of the US biosimilar market and resetting expectations.

CEO Craig Wheeler talked to Scrip about the challenging biosimilar market dynamics and the company's decision to end most biosimilar drug development. The path to value creation in biosimilars is not clear, he said.

With a well characterized genetic driver, a clear marker to show whether it's working, and available treatments that carry high annual costs, hemophilia may be a good testing ground for commercializing gene therapy, but payers still have to work out how to reimburse the one-time medicines.

With the first few cell and gene therapies launched in the US, the challenge of pricing and reimbursement – and the opportunity to set the standards in this area – was a repeated theme at the Alliance for Regenerative Medicine's Cell and Gene Meeting on the Mesa.

The three US FDA-approved anti-CGRP antibodies for migraine prevention have similar efficacy and matching prices, but Lilly thinks access to Emgality – including through value-based arrangements – along with the biologic's ease of use and headache-free data will differentiate the product.

With EU approvals in the bag for Ozalin, a novel oral midazolam solution for use in children, Switzerland-based Primex outlines plans for launch in Europe, and US development.

Mylan's Kokino spoke with Scrip about what he called the successful launch of the company's first biosimilar in the US, a version of Amgen's Neulasta, the state of the US biosimilar market and resetting expectations.

Heading into Phase III in 2019 is Lilly's dual agonist of GLP-1 and GIP, which has shown notable therapeutic effects on blood sugar and body weight in type 2 diabetics in a mid-stage clinical study. Meanwhile Lilly/Boehringer Ingelheim's SGLT2 inhibitor, empagliflozin, is being discussed with regulators with regard to its use in type 1 diabetics, an additional indication, following the release of full results from the EASE Phase III program.