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Commercial

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Sandoz And AbbVie Biosimilar Humira Settlement: What Does It Mean?

Sandoz has become the latest firm to sign a settlement agreement over biosimilar Humira with AbbVie, heralding imminent launch in Europe. In the US, it will hold off launching until September 2023.

Biosimilars Legal Issues Business Strategies

Pharma Q3 Results Preview: J&J, Novartis & Roche

Investors are keen to see how J&J's Remicade is holding up to biosimilar competition, especially now that Zytiga generics are on the way. Novartis is likely to play up the potential for new launches like siponimod in multiple sclerosis and Aimovig in migraine, while Roche is expected to continue delivering strong performance for core brands and expansion plans for Tecentriq.

Sales & Earnings Companies Commercial
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Companies

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Latest From Companies

Former Immunocore Boss Forster Replaces Haurum At F-star Helm

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.

 

 

Appointments ImmunoOncology

Merck of Germany's Hunt For MS BTKi Partner Boosted By Evobrutinib Data

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.

Clinical Trials Companies

China Vs. Cancer: Coverage For 17 Drugs Unveils Price Pressures, Commercial Battleground

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.

China Reimbursement

Finance Watch: With The Year's Biggest IPO, CFO Says Allogene Is Ready To Go 'Full Throttle'

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.

Financing Business Strategies

Early-Stage Cell And Gene Therapy Progress: Updates From Casebia, BlueRock, Athersys, Cynata

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

Regenerative Medicine Business Strategies

We Haven’t Ruled Out Drug Price Increases, Says Regeneron’s Schleifer

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.

Pricing Strategies Leadership
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Deals

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Latest From Deals

Venture Funding Deals: Atreca Raises $125m To Advance Solid Tumor Candidate

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.

Deals Financing

Carrick Targets Ovarian Cancer With BTG Deal, Entices Celgene’s Former Top Deal Maker

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

Deals Cancer

Ionis Catches The Eye With New Roche Alliance

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.

Ophthalmic Deals

Asia Deal Watch: Alvotech Signs On To Biosimilar Manufacturing JV In China

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.

Deals Commercial

Deal Watch: Astellas/Cytokinetics Extend Partnership, Make Progress On SMA Candidate

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.

Deals Business Strategies

Cure Pharmaceutical Targets Rx Entry For Film Strip While Now Focused On Supplements

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.

Drug Delivery Business Strategies
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Strategy

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Latest From Strategy

Can Lilly's Olumiant Prickle Xeljanz In India?

Lilly’s Olumiant has hit the Indian market, upping the level of competition in a rheumatoid arthritis sector that already includes the fellow JAK inhibitor Xeljanz from Pfizer and at least half a dozen biosimilar versions of Humira, among other products. But could pricing cloud Olumiant’s uptake?
India Commercial

Merck Steps Out Of Insulin Glargine Market, But Says It Remains Committed To Biosimilars

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.

Biosimilars Strategy

Cipla Rejigs Deck As Global Head Of Operations Moves On

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.

Leadership Appointments

More Manufacturing Rationalization On The Cards At Dr Reddy’s?

Dr Reddy’s quest to emerge as an “internationally cost-competitive and more nimble organization” is expected to entail further rationalization of the firm’s manufacturing network. The company may put on the block a formulations site in India, if the buzz on deal street is to be believed.
Commercial Strategy

Mylan Head Of Biologics Chrys Kokino On Fulphila Launch And US Biosimilars

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.

Biosimilars Strategy

Momenta Is Exiting Biosimilars; Is That A Bellwether For Biosimilar Sentiment?

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.

Biosimilars Business Strategies
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Market Access

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Latest From Market Access

Hemophilia Seen As Good Testing Ground For Commercializing Gene Therapy

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.

Regenerative Medicine Blood & Coagulation Disorders

Cell And Gene Therapies Test New Waters In Pricing And Reimbursement

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.

Reimbursement Regenerative Medicine

Lilly Looks To Emgality Access, Injector And Data To Differentiate Its CGRP Inhibitor

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.

Approvals Launches
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Market Intelligence

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Latest From Market Intelligence

Primex Pharmaceuticals Plots Launch Plans For Oral Pediatric Sedative

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.

 

Neurology Pediatrics

Mylan Head Of Biologics Chrys Kokino On Fulphila Launch And US Biosimilars

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.

Biosimilars Strategy

"Impressive" HbA1c And Weight Reductions Spur Phase III Plans For Lilly's Dual Incretin Agonist

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.

Metabolic Disorders Clinical Trials
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