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Home » Newsletters » BioWorld

BioWorld

Feb. 26, 2019

View Archived Issues

Gene therapy Sparky still, Roche following Novartis: $4.8M for Luxturna parent

Spark Therapeutics Inc. told BioWorld there was "not much more we can say beyond the press release" and the company wasn't offering executive interviews, but the buyout by Roche Holding AG generated vigorous buzz on Wall Street as pundits tried to guess which gene therapy firm might be next for a takeover in the space. Read More

Ipsen bulks up in rare disease with $1B bid for Clementia

DUBLIN – Ipsen SA is putting down $25 per share, or $1.04 billion in cash, to acquire Clementia Pharmaceuticals Inc. and is on the hook for a contingent value right (CVR) worth another $6 per share, or $263 million, which is tied to FDA acceptance of Clementia's NDA for its lead drug, palovarotene, in multiple osteochondromas (MO). Read More

Novartis exercises first of two options on Akcea CV drugs, triggering $150M payment

Amid a growing global incidence of cardiovascular disease (CVD), Novartis AG has exercised the first of two options it holds on antisense drugs developed by Ionis Pharmaceuticals Inc. affiliate Akcea Therapeutics Inc., triggering a $150 million payment to Akcea from Novartis and boosting its shares (NASADQ:AKCA) by 16.7 percent to $31.91 on Monday. Read More

Congressional feeding frenzy to continue over insulin, other Rx drug prices

U.S. prescription drug prices will be on the menu again Tuesday, as Congress continues to serve up a steady diet of outrage over what some biopharma companies are charging. Read More

Wall Street embraces GE sale of Biopharma biz to Danaher for $21.4B, puts IPO in doubt

General Electric Co.'s (GE) spinout of its Healthcare business in an IPO has been a highly anticipated med-tech industry event for 2019. But now all that is back into play. The Boston-based conglomerate has opted to sell its Biopharma business for $21.4 billion to Danaher Corp. That Biopharma unit accounted for about 15 percent, or about $3 billion, of the almost $20 billion in 2018 Healthcare revenues. Read More

Regulatory filings ahead as Foresee reports positive phase III prostate cancer data

HONG KONG – Taiwan-U.S. biopharma company Foresee Pharmaceutical Co. Ltd. said its core program, FP-001 LMIS (leuprolide mesylate injectable suspension) 25 mg, has shown positive phase III data, similar to those of its FP-001 LMIS 50 mg and marketed drugs of the same class. Read More

Australia looks to reduce barriers for generic drugs to enter the market

PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is asking industry stakeholders for feedback on a draft guidance to reform the generic drugs market authorization process. Read More

Regulatory front

Karyopharm Therapeutics Inc. (NASDAQ:KPTI) was still reeling Monday, a day ahead of its meeting with the FDA's Oncologic Drugs Advisory Committee. Hitting an all-time record for the Newton, Mass.-based company, nearly 16.6 million shares were traded Friday when the FDA released its briefing materials for the meeting, raising concerns that Karyopharm's lead agent, selinexor, wouldn't get support for accelerated approval to treat refractory multiple myeloma.  Read More

Earnings

Biomarin Pharmaceutical Inc., of San Rafael, Calif., said its net loss for 2018 decreased $39.8 million, or 34 percent, to $77.2 million, compared to $117 million in 2017. The net loss for the quarter ended Dec. 31 decreased to $3.6 million, compared to a net loss of $51.4 million for same period in 2017.  Read More

Financings

Melinta Therapeutics Inc., of Morristown, N.J., which is focused on the development and commercialization of antibiotics, said it received the initial $75 million disbursement under a convertible loan facility from Vatera Healthcare Partners LLC. In addition, an amendment to the facility agreement with funds managed by Deerfield Management Co. LP also became effective. Read More

Other news to note

TC Biopharm Ltd. (TCB), of Glasgow, Scotland, disclosed a collaboration with Trinity College Dublin to accelerate in-house production of medicines based on donor cell banks for the treatment of solid tumors. TCB will manufacture GMP-compliant candidates that will be combined with its off-the-shelf tumor-targeted T-cell platform to generate candidates to treat a range of cancer types. Initial studies are planned for late 2019. Read More

Clinical data for Feb. 25, 2019

Read More

Regulatory actions for Feb. 25, 2019

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