CFDA approved Pfizer’s Prevenar 13® for use in infants and children in China

Pfizer China has received approval from the Chinese Food and Drug Administration (CFDA) to market its pneumococcal 13-valent conjugate vaccine, Prevenar 13®, in China for active immunization for the prevention of invasive diseases (including bacteremic pneumonia, meningitis, septicemia, and bacteremia) caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in infants and children aged 6 weeks to 15 months.
Pneumococcal disease is a leading cause of vaccine-preventable deaths globally in children under five years old(1). In China alone, approximately 30 thousand children in this age group die due to pneumococcal diseases every year(2).
In China, the recommended Prevenar 13® immunization series is a primary series administered at 2, 4 and 6 months of age with a fourth (booster) dose administered at approximately 12~15 months of age.

Merck: € 250 million investments in China

Merck, inaugurated its € 170 million Nantong pharmaceutical plant, which is dedicated to producing high-quality pharmaceuticals on China’s Essential Drug List. Merck will invest around € 80 million in a Life Science Center near the Nantong pharmaceutical plant to manufacture high-purity inorganic salts, cell culture media products as well as ready-to-use media.
The first drugs from the plant are expected to be delivered to patients in the second half of 2017. Along with the investment of around € 80 million by the Life Science business sector of Merck, this adds up to a total of investment of € 250 million in its production value chain in China. These investments support Merck’s expansion in China, which is expected to become the world’s second-largest pharmaceutical market by 2018.
The Nantong pharmaceutical manufacturing site will focus on the production of Glucophage®, Euthyrox® and Concor®, Merck’s leading brands for the treatment of the major chronic diseases diabetes, thyroid disorders and cardiovascular diseases. With the next investment of € 90 million announced today, the facility is designed to accommodate full production capacity of up to 10 billion tablets a year by 2021.

FDA: OK for Roche’s TECENTRIQ (atezolizumab) for people with a specific type of metastatic lung cancer

The U.S. Food and Drug Administration (FDA) approved TECENTRIQ® (atezolizumab) for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumour has EGFR or ALK gene abnormalities.
This approval is based on results from the randomised Phase III OAK and Phase II POPLAR studies.

Bosch Packaging Technology India opens new manufacturing facility

Bosch Packaging Technology has a new facility at Verna, near Goa, that fulfill capacity expansion and meet the increasing demand of India’s fast growing packaging market as well as international markets. Numbers are huge: 33,000 square meters land, with an investment of Rs 34 crores (about 5 million euro); the new plant will aim at increased localization of new packaging machine production and make world class German technology affordable and available to the Indian market.

Lonza: a new lab in Switzerland

Lonza has opened its pharmaceutical Drug Product Services laboratory in the Stücki Science Park Basel (CH), Switzerland. With 1,300m2, the facility will provide services such as particle testing or container closure integrity testing to enable production of safer medicines, as well as services to trace impurities in pharmaceutical products such as detecting extractables and leachables from plastics used in manufacturing.
The drug development programmes will comprise formulation, stability, primary packaging, process development, and manufacturing to ensure usability and patient safety.

Novartis wins two Prix Galien Foundation Awards

Novartis has been awarded the prestigious 2016 Prix Galien USA Award for Best Biotechnology Product for Cosentyx® (secukinumab), as well as the Prix Galien Foundation “Discovery of the Decade” Award for Best Pharmaceutical Product for the drug Gleevec® (imatinib mesylate).
Cosentyx® was the first fully human interleukin-17A (IL-17A) antagonist approved by the FDA in 2015 for the treatment of adults with moderate to severe plaque psoriasis. Cosentyx® was also approved for the treatment of active ankylosing spondylitis and psoriatic arthritis in 2016.
Gleevec, a molecularly targeted treatment, rapidly became a therapy of choice for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and KIT (CD117)-positive gastrointestinal stromal tumors (KIT+ GIST)[3]. By showing that certain diseases can share a drug-sensitive target with seemingly unrelated ailments, and that molecular targeting can be medically and commercially successful, Gleevec helped establish a new paradigm for drug development.

Zambon and Fabbrica Italiana Sintetici (FIS) partners for the development of the Lonigo plant

Zambon and Fabbrica Italiana Sintetici (FIS) will be partners. Under the terms of the agreement FIS will take over the chemical plant in Lonigo (Vicenza), a branch of Zambon Chemicals (Zach), and Zambon will become a leading FIS customers.
This partnership ensures that the activities carried out by the Lonigo plant will remain part of the extended Zambon family in order to ensure continuity in the way of doing business, with a long-term time view that will allow investing in growth areas, and remaining committed to all employees.

PepsiCo and TB Alliance are partners in fighting tubercolosis

The non-profit organization dedicated to developing better and faster cures for tuberculosis, TB Alliance, entered a unique collaboration with food and beverage company PepsiCo designed to improve the treatment for children with TB.
As part of the partnership, PepsiCo will apply proprietary flavor and sensory expertise to help map and develop strategies that counter the bitter taste of TB drugs. In fact, many of today’s TB treatments are very bitter or unpleasant in taste and can lead to low tolerance and poor compliance - especially among children.
PepsiCo will not be paid for its efforts, and TB Alliance will have free access to apply the results to its drug development and treatment efforts.

Newsroom’s selection - Final copy approved on December 15th, 2016.