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Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT Admiral drug-coated balloon (DCB) in longer, 150 mm lengths. The new 150 mm length balloon, available in four, five, and six mm diameters, will provide greater treatment options for long lesions in patients with peripheral artery disease (PAD).
Bacteria are rapidly developing resistance mechanisms to combat even the most effective antibiotics. Each year in the United States over 23,000 people die as a result of bacterial infections that have no treatment options, according to the Centers for Disease Control. Infections with antibiotic-resistance bacteria are extremely difficult to treat, requiring costly or toxic medications that do not always work. Scientists are constantly working to understand the mechanisms bacteria use to outsmart antibiotics and develop resistance. These mechanisms include metallo-β-lactamases (MBLs), enzymes produced by bacteria that can bind to and inactivate antibiotics. Enzymes like MBLs are one way bacteria are defying all available tools and becoming antibiotic resistant.
Abbvie announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for ABT-414, an investigational antibody drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Glioma (DIPG), known to be highly aggressive and difficult to treat brain tumors found at the base of the brain.
The U.S. Food and Drug Administration approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors. ExAblate Neuro is manufactured by InSightec in Dallas, Texas.
Shire plc announces that the U.S. Food and Drug Administration (FDA) has approved Xiidra (lifitegrast ophthalmic solution) 5%, a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adult patients. Xiidra is the only prescription eye drop indicated for the treatment of both signs and symptoms of this condition. Shire expects to launch Xiidra in the United States in the third quarter of 2016.
Medtronic plc announced U.S. Food and Drug Administration (FDA) clearance of NuVent(TM), an EM sinus dilation system, for patients with scarred, granulated, or previously surgically-altered tissue - an expansion of indications. Patients coming in for revision sinus surgery (RSS) have these tissue characteristics. NuVent is the first and only balloon sinus dilation system with built-in electromagnetic (EM) surgical navigation technology that may help surgeons confirm anatomy and optimize placement2 during balloon sinus surgery. RSS may be needed when sinus surgery does not alleviate suffering, and can pose unique challenges due to potential scar tissue and altered anatomy from previous surgeries. Image-guided surgery may have advantages for some types of revision cases.3
India continues to win race in pharmaceuticals export over China as per government data. Pharmaceutical exports is leading China's export in important places like US, European Union (EU) and Africa. It is also noted that China's pharmaceutical export in EU & Africa is reducing gradually.
India’s pharmaceutical exports continued its lead over China in 2015. While India’s Pharma exports grew from USD 11.66 Billion to USD 12.54 Billion in 2015 recording a growth of 7.55%, China increased its exports of Pharma products from USD 6.59 Billion to USD 6.94 Billion showing a growth of 5.3% during the same period.
India moved ahead of China in all important markets such as US, European Union and Africa. India’s exports of Pharma products to US jumped from USD 3.84 Billion to USD 4.74 Billion, a growth of 23.4% as against China’s Pharma exports to US which moved from USD 1.16 Billion to USD 1.34 Billion in the same period showing a growth of 15%.
India maintained its lead with growth in EU and Africa recording exports of USD 1.5 Billion and USD 3.04 Billion respectively while China’s exports to EU & Africa showed a declining trend in both the markets.
AMRI has completed the acquisition of Prime European Therapeuticals S.p.A., also known as Euticals. The acquisition positions AMRI as one of the largest independent developers and suppliers of API to the pharmaceutical industry, and in particular, provides the company with an established custom synthesis presence in key European markets.
Euticals is a privately-held company headquartered in Lodi, Italy, specializing in custom synthesis and the manufacture of active pharmaceutical ingredients (APIs).
AMRI financed the EUR 315 million transaction through the issuance of approximately 7.1 million shares of AMRI common stock (valued at signing), seller notes totaling EUR 55 million and the remainder in cash. In connection with the acquisition, AMRI secured USD 235 million in incremental borrowings under its existing Senior Secured Revolving Credit Facility, which bears interest at LIBOR with a floor of 1% plus 475 basis points, and repaid its USD 30 million revolving credit facility. AMRI intends to provide updated 2016 financial guidance, including the impact of the Euticals acquisition, in early August in conjunction with the companys second quarter financial results.
Mr. Marth added: "This significantly expands AMRI's customer base, further diversifies our revenue streams, and moves us significantly closer to our goal of reaching USD 1 billion in annual revenues by 2018. The Euticals acquisition accelerates our company's strategy to become a global, preeminent provider of contract research, development and manufacturing services to the pharmaceutical industry, while at the same time enhancing our ability to expertly serve our customers.
The 7.1 million shares of AMRI common stock issued in connection with the transaction were offered and sold outside the United States to Lauro Cinquantesette S.p.A. (Lauro 57), the sole stockholder of Euticals and an eligible investor pursuant to Regulation S of the Securities Act of 1933, as amended. Such shares have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration under or an applicable exemption from such registration requirements. This press release does not constitute an offer to sell, or a solicitation of an offer to purchase, the shares in any jurisdiction in which such offer or solicitation would be unlawful.
Nomura acted as exclusive financial advisor to AMRI in connection with this transaction and Goodwin Procter LLP and LCA Studio Legale acted as AMRI's legal advisors. Lincoln International acted as sole financial advisor to Lauro 57, and Chiomenti Studio Legale and Debevoise & Plimpton LLP acted as Lauro 57s legal advisors.
Accelerate Diagnostics, Inc. announced the submission of a De Novo request for Evaluation of Automatic Class III Designation to the U.S. Food and Drug Administration (FDA) for its Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for positive blood culture samples.
BioLife Solutions, Inc., a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers, announced that it has entered into a ten-year supply agreement with Kite Pharma, a leading developer of chimeric antigen receptor (CAR) and T cell receptor (TCR) products for various cancers.
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